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| Marck Biosciences' India facilities--Courtesy of Marck Biosciences |
The FDA in March issued an import alert against what was then a Marck Biosciences sterile manufacturing plant in Kheda, India. A July warning letter posted today explains why. Employees recorded data for functions that were not performed. Records, if kept at all, were often put on "scratch paper." The bathroom was filled with mold and an exit loading dock was littered with dead and decaying frogs.
"We expect that you hire a third party auditor, with experience in detecting data integrity problems, to assist you with this evaluation and assist with your overall compliance with cGMP," the FDA said in its warning letter, issued to Marck, which changed its named to Amanta Healthcare at the end of June.
The inspectors found multiple instances of missing or faked records. In fact, the FDA said, "Employees interviewed during the inspection admitted that your firm recorded activities in batch records that were not performed." It said "unofficial" visual inspection records were signed that had data different from official batch records. The company insisted to the FDA that a survey of 848 random batch records found discrepancies in just 2.5% of the cases. The FDA inspectors did their own figuring and came up with 76 cases in 156 batches, a somewhat higher 48% rate.
There was evidence that some rejected drugs were in fact released to clients, like one for which official records showed it was rejected on Oct. 18, 2013, but other records showed it was released from quarantine a week later.
On the sanitation side, investigators noted significant mold growth in the washroom located at the entry to the sterile manufacturing area and that the ceiling in there had "caved in." Investigators saw "numerous dead insects in the Sample Pass Through Room," near the sterile filling line of a parenterals facility. "In addition, dead and decaying frogs were found next to the product exit dock."
The ban on the Marck plant adds it to a growing list of Indian drugmakers, including some of the largest like Ranbaxy Laboratories, Sun Pharmaceuticals and Wockhardt, that have had plants banned for some of the same kinds of issues. Last week, Wockhardt reported that its profits for the last quarter were down nearly 95% as bans on two plants have devastated its sales in the U.S. Indian regulators, urged by the FDA, have indicated they are ready to step up their own inspections and oversight, even as the FDA is building up its inspection force in the country.
- here's the warning letter
- the import alert can be found here