Top 3 Most Outrageous Violations of cGMP by Pharmaceutical Companies

Over the years, we have observed  FDA warning letters that have some rather serious, alarming and sometimes even amusing details about cGMP violations. Read on to find out about three of the most outrageous violations of cGMP by pharmaceutical companies in recent times.

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1.  Document shredding caught on camera at Hetero labs

In December 2016, the Indian oral solid dose manufacturing facility of Hetero Labs Limited in Hyderabad received a 13-page observation of FDAs Form 483. When FDA investigators reviewed Hetero’s closed circuit TV, they identified a document shredder that had been introduced into the firm’s document storage area merely four days before the FDA inspection. Extensive shredding of what appeared to be batch packaging records and batch manufacturing records was recorded on camera. Individuals were observed shredding documents in at 1:13 a.m. in the dead of the night.

Hetero Labs tried to waive off the footage as that of their cleaning staff shredding documents. They did not provide any documentation of what had been shredded. Also no explanation was given for introducing the document shredder into the “Documents Storage Area” or the suspicious timing of the activity. 

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Source -https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/cderfoiaelectronicreadingroom/ucm537060.pdf

 2. Improper Urinal Drainage and Destruction of Records at Wockhardt

 Indian drugmaker Wockhardt Ltd. has been under FDAs radar for a long time. Under FDA’s import alert since 2013 for violations of good manufacturing practices, their Ankleshwar plant being the third such facility to face such an action in 2016. The warning letters received by Wockhardt mention some truly unusual practices.

 During a 2013 cGMP inspection the FDA investigator found torn data records in the waste area. He asked a QC officer to bring those documents for FDA review. The employee returned with about 20 documents, none of them being the data documents that were seen in the waste area. Even upon repeated questioning he insisted that those were the records that the investigator had seen. 

So, the investigator went back to the trash area and discovered that the documents had been kept in a different bag. The documents contained information about master batch records, stability protocols and anti microbial effectiveness. Wockhardt was accused of impeding the investigator and trying to to delay the audit.

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In the same letter, a violation of 21 CFR  211.52 mentioned that , the washing and toilet area, which was 20 feet from the entrance to the area where employees gowned to enter the sterile formulation area, had urinals that did not have proper drainage. Urine was falling directly onto the floor and was collecting there in an open drain. In addition, there was stagnant urine and extensive growth of mildew and mold, and all this was happening right adjacent to the sterile formulation manufacturing facility!
 

Source -https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm361928.htm

 3. Thrash bags of documents at Sun Pharma

 On May 7, 2014, the FDA released a warning letter to the Karkhadi (Gujarat) plant of Sun Pharmaceutical Industries Limited, a pharmaceutical manufacturer in India. Among the noted issues were, failure to record complete data, deleting data files, declaring samples that failed FDA requirements as “unofficial tests", and reporting only good test data as “official” from a sample batch.

burned documents

FDA investigators found about 10 garbage bags filled with partially destroyed manufacturing documents. They also found three partially filled unidentified bags in the company’s material warehouse. Upon questioning the employees were unable to determine conclusively the identity or status of the material.

Source - https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm397054.htm

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Posted on Jul 11, 2018 12:07:47 PM by Vivek Gera

Vivek Gera

Written by Vivek Gera

Vivek is the CEO of LeucineTech, a digital compliance platform that reduces the risk of drug FDA non-compliance (due to cross-contamination) by 80%.

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