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Tags: fda lab drugs inspection violation health-code chemjobber.blogspot.com
Clipped on: 2018-08-19

1. HELPING CHEMISTS FIND JOBS IN A TOUGH MARKET. 2. TOWARDS A QUANTITATIVE UNDERSTANDING OF THE QUALITY OF THE CHEMISTRY JOB MARKET.

Showing posts with label warning letter of the week. Show all posts
Showing posts with label warning letter of the week. Show all posts

Wednesday, August 15, 2018

Warning Letter of the Week: insanitary conditions edition

(From the inbox): Via a missive from the Director of Division of Pharmaceutical Quality Operations IV to the owner of BioDiagnostic International, some alarming comments:
Insanitary Conditions Violations
You manufacture [redacted], a drug product intended for vaginal use as a hemostatic solution to stop bleeding after cervical biopsies. During the inspection, our investigator observed filthy conditions in your facility, including dirty equipment and utensils covered with unknown residue. A large metal roll-up door at the entrance to your facility was open to the outdoors, while an open pot you use as a mixing vessel contained in-process material and was not covered. The insanitary conditions observed at your facility failed to protect drug products from contamination with filth.

CGMP Violations 
1.    Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).

Our investigator documented that you have an employee food preparation area within your drug manufacturing area with no separation between open manufacturing equipment, cooking utensils, and personal-use items. The practices observed at your facility, which was observed open to the outdoors, increase the likelihood of your drug products becoming contaminated.
Cooking utensils? That sounds... yucky.  

Wednesday, August 1, 2018

Warning Letter of the Week: "trial analysis" edition

A letter from the Center for Drug Evaluation and Research to the President and CEO of Yuki Gosei Kogyo Co., Ltd. of Tokyo: 
1.      Failure to maintain complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards. Your firm does not ensure that complete data from testing of your API are included in the official batch record and reviewed by your quality unit. For example, you reported passing results for related substances testing of [redacted] lot #[redacted] analyzed starting at [redacted] on July 28, 2015. However, our investigator found unreported analyses including out-of-specification (OOS) results for the same lot acquired earlier on the same date, and on the next day as the reported results. You failed to include this data to be reviewed by your quality unit prior to the release of the lot. Our investigator documented the same pattern with other products not intended for the U.S. market.

In your response, you explained that this “trial analysis” was performed on the sample solution for conditioning the high-performance liquid chromatography (HPLC) column. However, your explanation did not address why the “trial analysis” was performed using a sample solution instead of a standard solution, or why you ran this extra analysis in addition to the system suitability test, which verifies that a chromatographic system is adequate as set forth in USP 621.

You also acknowledged that a retrospective review conducted after the inspection found additional instances of unreported electronic data in original batch records. Your review only assessed laboratory data and did not assess all parts of your facility’s operation where CGMP information is generated and maintained. In addition, you failed to provide details of your review criteria and methodology. 
These FDA inspectors, picky-picky! 

Wednesday, July 18, 2018

Warning Letter of the Week: recycling consumables edition

A dispatch from the Center for Drug Evaluation and Research to the Managing Director of Claris Injectables Ltd. in Gujarat, India: 
1.    Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). 
Your firm invalidated out-of-specification (OOS) results without adequate investigation and scientific justification. Examples include: 
....In March, 2017, you obtained OOS results for the [redacted] impurity during stability testing of [redacted] injection batches [redacted]. You suspected the analyst may have incorrectly rinsed the HPLC vials. New samples prepared and tested by a second analyst using both the original column and a new column, as well as old and new vials, also yielded OOS results. Although you lacked sufficient evidence, your investigation concluded that the OOS results were due to sample vial contamination. You invalidated the OOS results after obtaining passing results from testing retain samples.
Rinsing HPLC vials??!?!?

(Someone who does science in the United States probably has no idea as to the constraints around consumables in the developing world. But still!)

Wednesday, July 11, 2018

Warning Letter of the Week: throw it all in there edition

A note from the Center for Drug Evaluation and Research to the General Manager of Foshan Jinxiong Technology Co., Ltd.: 
4.    Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
You lacked complete information related to the production and control of each lot. For example, you failed to have specific identification for each  lot of component, and production equipment, used in manufacturing. You also failed to have unique lot or control numbers for the distributed drug product. You provided our investigator with a list of more than [redacted] batches manufactured in 2017 that lacked this basic information.

In your response, you described your new lot numbering system and how you revised your production records. You also provided a copy of the revised production record.
Figuring out a way to accurately and robustly number manufacturing batches is a non-trivial task. Not numbering them at all is a pretty bold and simple solution! 

Wednesday, June 20, 2018

Warning Letter of the Week: fourth time's the charm edition

A greeting from the Center for Drug Evaluation and Research to the chairman of the board of IDT Australia:
2. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. (21 CFR 211.194(a)). Our review of your laboratory records revealed that you failed to report non-conforming test results on multiple occasions in multiple parts of your operations.

Analytical TestingDuring testing of [redacted] exhibit batch [redacted] in March 2016, three consecutive identity test failures occurred. The fourth test passed and you reported this conforming result. You did not include the three failures in the data package submitted to the quality unit for review or your application submission for this product. You did not conduct an investigation into the non-conforming results. At the time of the inspection, you were unaware that your analysts had not reported the failing results to your quality unit for review.
Surely those first three tests didn't mean anything.  

Wednesday, May 30, 2018

Warning Letter of the Week: REP edition

Via a letter to the CEO of the New England Confectionery Company, Inc. (the makers of Necco Wafers and Sweethearts), this blistering letter: 
1.    You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests as required by 21 CFR 117.35(c). Specifically, during the inspection, FDA investigators noted evidence of rodent activity in the following food storage areas in your facility:
Rodent excreta pellets (REPs) too numerous to count (TNTC) and evidence of wide spread rodent activity were identified in multiple areas throughout the plant, on raw material, and components of ready-to-eat (RTE) product. Specifically, our investigators noted REPs on the floor across from the “Sweethearts” production staging area, the floor of the “Sweethearts” cooling room, the floor of the peanut roasting room between pallets containing empty drums of “Mary Jane Peanut Butter”, in multiple locations on the floor of the raw material storage warehouse, in multiple locations on the floor of the finished product storage warehouse, the floor and storage racks of the second floor maintenance area, in multiple areas on the floor of the molding room and the loading dock. Ripped bags of sugar and ripped bags of almonds appearing to have been re-sealed were observed. Spilled sugar and almonds were observed on the floor. REPs were observed among spilled almonds on the floor.
My jaw has dropped TFTM (too far to measure.) Yuck.  

Wednesday, April 25, 2018

Warning Letter of the Week: accidental deletion edition

A friendly note to the president of Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. in Yunnan, China from the folks at the Center for Drug Evaluation and Research:
2.      Failure to maintain complete data derived from all laboratory tests conducted to ensure your API and intermediates comply with established specifications and standards.
Your firm performed HPLC assay testing for [redacted] API release to the United States, along with stability and intermediate testing, on your Waters HPLC system between September 25, 2011, and May 5, 2017. Official quality control data packages presented to the quality unit for batch disposition decisions reported the results of testing performed during this timeframe on this equipment. During our inspection, when we sought to reconcile assay results reported in the quality control data package for a released batch with the underlying electronic data, you responded that you could not provide the electronic data from laboratory analyses on this equipment for the above period of several years. You explained that the electronic data in question had been deleted by accident and was no longer available. (emphasis mine)

In your response, you stated that the electronic data had been downloaded to a “mobile hard disk for backup” and that you would be able to recover the data after you have upgraded your HPLC software. However, you did not include evidence to support recovery of deleted electronic data or demonstrate how you will prevent such deletions from recurring in the future.
Oops! Sorry! Never happen again, I promise.  

Wednesday, April 11, 2018

Warning Letter of the Week: "we made it, it's good" edition

1.    Your firm failed to maintain adequate separate defined areas necessary to prevent contamination or mix-up (21 CFR 211.42(c)).
You manufacture several over-the-counter (OTC) drug products and medicated otic and oral care products under contract. These drugs include [redacted] Ear Wax Drops, [redacted] Oral Rinse, and fluoride toothpastes. You also manufacture numerous non-pharmaceutical materials in your facility, including a weed killer and adhesive remover. 
You did not utilize any quarantine markings or physical segregation of finished drug products from the lawn care and cleaning chemicals in your warehouse. You did not designate your quarantined finished drug products with quarantined status. During the inspection, your Vice President of Operations stated that your firm does not quarantine any finished products before they are released by quality because you “thought of the product as good once it was manufactured.”

Your response stated that your warehousing space is “tight,” and you have recently acquired additional off-site space to store packaging components. You also stated that you would implement a procedure by July 1, 2017, for labeling the status of finished drug products.
Just in case you were thinking about mixing the lawn care products and the toothpaste... 

Wednesday, March 7, 2018

Warning Letter of the Week: PC desktop recycle bin edition

A friendly note to the general manager of Zhejiang Ludao Technology Co., Ltd. from the Center for Drug Evaluation and Research: 
1.    Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
Your firm lacks basic laboratory controls to prevent changes to paper and electronic records for your over-the-counter (OTC) drug products. You were not able to provide analytical test data for three batches of [redacted] spray and one batch of [redacted]. We found that you created certificates of analysis (COA) for these four batches before they were manufactured and tested.

When questioned, your firm acknowledged falsifying the analytical test results on the COA you used to support release and distribution of [redacted] spray and [redacted] drug products to the United States.

In addition, we found three electronic data files in the electronic recycle bin of the stand-alone HPLC system you used to test finished drug product [redacted] spray. Because this instrument lacks back-up and audit trail capabilities, we could not determine how frequently test data obtained prior to “official” batch testing was discarded. You were unable to explain why these electronic files were deleted.
Always empty the recycle bin!  

Wednesday, February 28, 2018

Warning Letter of the Week: busted gaskets edition

A friendly missive to the CEO of Alchymars ICM SM Private Limited in Chennai, India from the good folks at the Center for Drug Evaluation and Research:  
2. Failure to properly maintain equipment and to keep complete records of major equipment maintenance.
Our investigator found damaged product-contact surfaces on your multi-product equipment. For example, the manhole gasket of [redacted]111 was deteriorating and wrapped in peeling tape. A gasket on the [redacted]102 was also cracked in one area and wrapped in peeling tape.

Your SOP/ENG/39-1, Gasket Management for Equipments and Pipelines which are in Direct Contact with the Product, section 4.18, requires you to replace gaskets in critical areas, including gaskets for [redacted]111 and [redacted]102, [redacted]. Your firm was unable to provide gasket replacement records for this equipment during the inspection.

Furthermore, the most recent records of your firm checking the condition of the gaskets for [redacted]102 were from January 2017, more than [redacted] before our inspection.

This is a repeat observation from our February 2015 inspection. We also note that you have found deteriorating gaskets to be the root cause for finished API particle complaints.

Your response is inadequate. You stated that the “involved gasket was immediately substituted” but did not evaluate all other gaskets on your manufacturing equipment. You indicated that you will update your procedure to require a supervisor walk-through to assess product contact surfaces, but did not include sufficient detail (e.g., frequency of equipment inspection). You also failed to address the lack of gasket maintenance records.
Gaskets are cheap, aren't they? Better a couple of bucks for gasket than particles in your API... 

Wednesday, November 1, 2017

Warning Letter of the Week: reused results edition

From a love note from the Center for Drug Evaluation and Research to the CEO of Kim Chemicals Private Ltd. of Maharashtra, India: 
During our inspection, our investigator observed specific violations including, but not limited to, the following.

1.    Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
For example, multiple batches of Vaporizing Chest Rub and [redacted] failed to meet finished product specifications, including active ingredient content. Despite these failing test results, you shipped these drugs to the United States.

Additionally, your staff informed our investigator that batches are not routinely tested. Instead, your firm re-uses test results from a past batch produced several years ago, and enters those results on certificates of analysis for new batches.

Your brief response indicated that your firm is performing batch testing, but included no raw data or test results. 
3.    Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
You had no records to support the analytical testing results reported on your certificate of analyses. Your firm indicated to our investigator that you document finished product analysis on a pad of paper, transcribe the test results onto a certificate of analysis, and then destroy the piece of paper. There is no assurance that the testing was conducted in the first place, and there is no record that any associated calculations were performed.
 That's one way to save on pesky laboratory fees! 

Wednesday, September 27, 2017

Warning Letter of the Week: honest QA manager editions

A love note from the Center for Drug Evaluation and Research to the general manager of Shandong Vianor Biotech Co., Ltd:
2.    Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). 
Your laboratory analysis revealed that [redacted] lot [redacted] was subpotent. However, the certificate of analysis (CoA) provided showed that it was within specification. When questioned about why the CoA reported passing results even though the batch actually failed, your quality unit manager stated, “I made a mistake.”

3.    Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Our investigator observed what appeared to be rusted and corroded screws, [redacted] fluid and debris, and metallic mesh material on the product contact surfaces of [redacted] located in your facility.

Access to information during inspection
During the inspection, you initially barred our investigator from accessing a room identified as a laboratory. You eventually allowed the investigator to inspect the laboratory, but he found that it contained no equipment. You then stated that the laboratory was offsite at a [redacted] residence and that you could not give our investigator access as it was not a convenient time.
I think "I made a mistake" was a new one for a warning letter.  

Wednesday, September 13, 2017

Warning Letter of the Week: poisoning infants edition

A warning letter from the Center for Drug Evaluation and Research to the CEO of Homeolab USA Inc.: 
During our inspection, our investigator observed specific violations including, but not limited to, the following.

1.    Your firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)).
Your firm released multiple lots of homeopathic in-process powder blends prior to attempting to validate your manufacturing process. You manufacture [redacted] homeopathic in-process powder blend mixtures which you send to Raritan Pharmaceuticals Inc. (Raritan), a contract manufacturing organization, to produce finished homeopathic drug products for the United States (U.S.) market. Some of your powder blend mixtures are manufactured from ingredients that pose potentially toxic effects. For example, your Infants’ Teething Tablet [redacted] contains belladonna. Raritan uses this powder blend mixture to produce finished drug products for infants and children, a population vulnerable to the toxic effects of belladonna. You shipped [redacted] lot [redacted] of Infants’ Teething Tablet [redacted] to the U.S. market before evaluating whether your manufacturing process was reliable and reproducible.

Your operators use a [redacted], an inherently variable process, to [redacted] produce in-process powder blends, including those made from toxic ingredients. You did not test the in-process powder blends for adequacy of mixing to assure uniformity and homogeneity prior to release and shipment to your contract manufacturer, Raritan.

FDA collected samples of your in-process drugs ([redacted] lot [redacted]) during our September-October 2016 inspection of Raritan. FDA analyses indicated that your in-process drugs were not homogeneous in composition.

Raritan used your powder blends to contract manufacture adulterated finished drug products that you marketed for use in infants and children in the United States. FDA analysis of finished drug products made from your in-process blends also demonstrated non-homogeneous composition. We acknowledge that the teething tablets made from your non-uniform powder blends were recalled.
For those who need some context, Hyland's Teething Tablets are (or were) a fairly common product in American drug stores. They are believed (incorrectly, I assert) to relieve teething pains in children. (I recall turning up my nose at these products because they are labeled as homeopathic.)

As it turns out, they weren't very homeopathic, and the health news website STAT had a long article in February detailing the many hundreds of children who were injured (and the 10 children who died) by the belladonna (a poison!) that was used as the active ingredient in these tablets.

As a parent and a scientist (and someone who works around the pharmaceutical manufacturing space), I am saddened and angered that non-homogeneous blending was the final hole in the Swiss cheese that allowed these poisonous tablets to be released to the public.

(Don't miss the "limited photography" section in the warning letter: "Your consultant impeded the inspection by preventing our investigator from photographing this piece of equipment.")

Wednesday, August 30, 2017

Warning Letter of the Week: rat droppings edition

A short missive to the general manager of Bicooya Cosmetics Limited in Zhejiang, China from the Center for Drug Evaluation and Research: 
1. Your firm failed to keep the buildings used in the manufacture, processing, packing, or holding of a drug product free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)). 
Our investigator observed rodent feces throughout your facility:
  • in direct proximity to the filling machine where you manufacture OTC drug products
  • in direct proximity to the [redacted] system, which produces [redacted] incorporated in your drug products
  • throughout the warehouse, around both raw materials and finished drug products
  • Your over-the-counter [redacted] drug products include [redacted] ointments and [redacted]. 
...4.    Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).  
Our investigator requested batch records for OTC drug product lots distributed to the United States, including [redacted] Ointment and [redacted]. You were unable to provide batch records.

In addition, analytical testing records were missing data, dates, and signatures. Our investigator observed your staff altering information in analytical test reports during the inspection. For example, you significantly altered the analytical testing report for [redacted] Ointment lot (b)(4), although this lot had already been distributed to the U.S. market.
"Hey, that's a FDA inspector - better keep altering that analytical report!" I would love to know the context behind that one. 

Wednesday, June 21, 2017

Warning Letter of the Week: Sticky notes edition

A short epistle from the Center for Drug Evaluation and Research to Mr. Jun Wu, the Chairman of China Resources Zizhu Pharmaceutical Co., Ltd.:
3.    Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP, and meet established specifications for quality and purity.
Our investigators found batch production records that contained blank or partially completed manufacturing data and lacked dates and signatures for verification. For example, in your [redacted] plant, our investigators found a batch record for [redacted] starting material, batch [redacted], with sticky notes from the quality assurance department directing operators to enter manufacturing data, such as missing weight and volume entries. Also, your quality unit did not approve this batch record before the material was used in further manufacturing.

All data in CGMP records must be complete and reliable so it can be evaluated by the quality unit during its batch review, as well as maintained for additional CGMP purposes.

Other documents—including cleaning records and equipment use logs—were also found to be partially completed, without dates and signatures for verification, or with pages or spaces intentionally left blank for documentation at a later time.

Your quality unit was aware of these unacceptable production department practices but did not ensure they were corrected.
It's interesting to see what CDER is pointing out, i.e. that the quality unit wasn't stopping the production of the material; rather, it looks like the material was pushed forward, and the batch records were never filled out before the inspectors arrived. 

The checking of batch records by QA (and the properly-documented correction of such) is such a routine part of cGMP production, but it's easy to take it for granted. 

Wednesday, May 3, 2017

Warning Letter of the Week: frozen croissants edition

A short note from the FDA to the owner of C & B Croissants Corporation: 
During an inspection of your firm located at 1339 W. Gaylord St., Long Beach, CA on October 25 through November 4, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a variety of frozen croissants.... 
1. Your firm failed to take measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigator discovered evidence of insect and rodent activity near foods stored in your food processing facility. For example, the following items were discovered in the production areas of the bakery during the inspection:
  1. In the weighing/ ingredient storage room off the main processing room there were about 8 apparent rodent excreta pellets on an unused slicer adjacent to a gnawed package (containing a video); and approximately 13 apparent rodent like excreta on the floor beneath the unused slicer. The table holding the slicer was about 12 feet away from uncovered buckets holding dry ingredients used to make plain croissant dough for the current day’s production.
  2. In an enclosed room directly adjacent to the processing room, approximately 5 live cockroaches (less than 1” long each) were observed. In addition, apparent rodent excreta pellets were observed in the northwest corner (30 approximately), northeast corner (17approximately), and center of the room (12 approximately). No food or food packaging material was stored in this room; only small pieces of dried dough like residue.
  3. Front and back roll-up doors remained open during the first day of the inspection, with no barriers to prevent pests and vermin from entering the warehouse areas in both the front and the rear of the building.
  4. About 3 birds flew through the front warehouse door into the warehouse and then flew out (this is a repeat observation from the FDA inspection in 2010).
  5. One fly near the 3 compartment sink in the processing room and 3 flies on a table near the employee break room...
Just in case you thought the CDER folks got to have all the fun...

Wednesday, April 26, 2017

Warning Letter of the Week: integration inhibition edition

A friendly missive from the Center for Drug Research and Evaluation to the Director and President of Operations of Divi’s Laboratories Ltd. (Unit II): 
1.      Failure to ensure that test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and/or purity.
Our investigators observed that the software you use to conduct high performance liquid chromatography (HPLC) analyses of API for unknown impurities is configured to permit extensive use of the “inhibit integration” function without scientific justification.  For example, our investigator reviewed the integration parameters you used for HPLC identification of impurities in release testing for [redacted]. These parameters demonstrated that your software was set to inhibit peak integration at four different time periods throughout the analysis. Similarly, in the impurities release testing you performed for [redacted], your HPLC parameters were set to inhibit integration at four different time periods throughout the analysis.

Inhibiting integration at various points during release testing for commercial batches is not scientifically justified. It can mask identification and quantitation of impurities in your API, which may result in releasing API that do not conform to specifications.
I didn't know you could do that - the things you learn.... 

Wednesday, April 5, 2017

Warning Letter of the Week: identification edition

In a missive from the Center for Drug Evaluation and Research to Mr. Prashant K. Tewari, the Managing Director of USV Private Limited, an unusual failure mode for a warning letter:
4.    Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
[Redacted] failed identity testing. You accepted a passing retest result without any investigation of the failed result.

In your response, you state that you attempted to conduct a retrospective investigation of the analysis which occurred more than a year earlier, and tentatively concluded that the out-of-specification (OOS) result might have been caused by analyst error. Also, your investigation recommends replacement of the polarimeter on which the OOS result was obtained.
How do you fail identity testing of a compound? Isn't that just "do the IRs match?" Whoa.  

Wednesday, March 22, 2017

Warning Letter of the Week: renaming samples edition

A dispatch from the Center for Drug Evaluation and Research to the general manager of Jinan Jinda Pharmaceutical Chemistry Co., Ltd.:
1.    Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP, and meet established specifications for quality and purity.
Your quality control laboratory disregarded multiple out-of-specification (OOS) impurity results without justification. For example, on September 22, 2015, you encountered an OOS unknown impurity peak during high performance liquid chromatography (HPLC) testing of [redacted] 36-month stability batch [redacted]. You terminated the analysis. Testing of a new sample also showed the OOS impurity peak. The chromatogram was then manually rescaled, which hid the presence of this peak. Your laboratory set the integration parameters to omit this peak from integration. Because the peak was omitted, the quality unit was not provided with full information to evaluate whether the stability batch, and potentially other marketed batches, continued to meet quality standards.

In addition, your audit trail showed that from July 1 to 2, 2015, you performed seven sample injections of [redacted] 60-month stability batch [redacted] to test for impurities using HPLC. You permanently deleted the first five sample injections. You then renamed the last two injections and reported that they met specifications. [emphasis CJ's] Your quality unit failed to identify and address these serious data manipulations.
Seems legit.  

Wednesday, March 15, 2017

Warning Letter of the Week: questionable water source edition

An unhappy epistle from the Food and Drug Administration to the Chief Executive Officer of 
Badrivishal Chemicals & Pharmaceuticals: 
1.    Failure to validate and monitor the water purification system to ensure that water is of appropriate quality and suitable for its intended use.
During the inspection, our investigators found that your water purification system was not adequately monitored and controlled. Because you use water as a drug component and for cleaning your facility and equipment, these failures pose significant risk to the safety of your drugs.

Source waterYou failed to test the source water for your [redacted] water system. The source water emanates from a nearby river and passes through farmland, where it is subject to agricultural runoff and animal waste, before reaching your facility. Your firm stores the source water in an [redacted] tank that has a large [redacted]-facing hole that is open to the environment. Your storage method does not protect your water from dirt and other contaminants, or from the ingress and proliferation of pests and objectionable organisms.
 Well, that sure doesn't sound very appetizing. Here's hoping they fix that hole. 
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