Urine Puddles and Destroyed Records – FDA Hits Wockhardt Hard In Latest Warning Letter

Urine Puddles and Destroyed Records – FDA Hits Wockhardt Hard In Latest Warning Letter

July 24th, 2013 // 12:53 pm @

Latest FDA and cGMP Compliance News

Over the years, we have seen a number of FDA warning letters that have some rather alarming and sometimes even amusing details about cGMP violations. But the warning letter that Wockhardt received on July 18 had some truly unusual practices and violations noted that are going to be watched by FDA for a long while. Wockhardt, by the way, has been banned from making drugs in Europe.

During a cGMP inspection in March, the FDAer noted that there were torn data records in the waste and trash area. He asked a QC officer to take those documents so the FDAer could review them. The employee came back with a couple dozen documents and none of them were the data papers that were noted in the trash and waste area. He insisted that those were the records that the FDAer had seen.

So, the FDAer went back to the trash area and discovered that the documents had been put in a different bag. The documents had information on them about master batch records, stability protocols and anti microbial effectiveness. Wockhardt was stalling FDA to delay the audit. Not a good sign of things to come.

Next the washing and toilet area, which is 20 feet from the entrance to the area where you gown to enter the sterile formulation area, had urinals that did not have proper drainage. So, employee urine was falling straight onto the floor and was collecting there in an open drain. There was old urine in puddles and there also was mold and mildew…right next to the sterile formulation manufacturing facility!

This is similar to an inspection in 2011 when the FDA found there was a 10 gallon mixing vessel in a storage room at a Ben Venue Labs plant that was full of urine. This caused a police investigation and was a major embarrassment for the unit of Boehringer Ingelheim.

Another issue that Wockhardt had was that it had two sets of batch records. FDA found that there were unofficial records for about 70 batches of finished drugs that were ripped in half in a trash area. The records had data that stated some batches had not met visual inspection specs. The official records stated that they had.

The uncontrolled documents stated that 15% of the vials included defects, such as fibers, glass particles, black particles, sealing defects and variations in volume. A defect rate above a redacted percentage mandates an investigation at Wockhardt, but the senior production official conceded that no investigations are done.

There also were incomplete laboratory records kept for stability tests. Wockhardt is supposed to perform sample analysis for liquid chromatography before it collects any official data. But these trial runs were never recorded in the equipment use books, and the sample prep data was destroyed. There was no way to do any analysis of the data.

There also were incomplete training records for GMP activities and for handling materials that were sterilized; improper handling of media fill vials; the operating of filter integrity testing equipment; improper line clearance for filling, washing, manufacturing and sealing areas.

Worse, the letter noted that many infractions were noted during earlier cGMP audits. The agency wants to see a corrective action program and it recommends that an external auditor handle it. FDA also stated that the auditor do interviews of both former and current employees at Wockhardt facilities.

Note that FDA said ‘facilities,’ is in more than one.

The warning letter ends on an ominous note, with the acting director of the Office of Manufacturing and Product Quality in the Office of Compliance at CDER saying that the examples in the letter raise serious concerns about the reliability, integrity and accuracy of the data at the facility. This means that serious regulatory action is in the works if Wockhardt doesn’t get the bathrooms cleaned up and the many other problems noted above.

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