8/20/2014 6:43:22 AM
FDA Finds Falsified Data, Serious Mold And Decaying Frogs At Marck Biosciences
August 20, 2014
By Mark Terry, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration (FDA) has sent a warning letter to Indian company Amanta, formerly Marck Biosciences, for a range of inspection breaches and possible falsification of records. Amanta’s facility in Kheda in the Gujarat region of India, was inspected by the FDA in October and November of 2013 and numerous unsanitary conditions were reported.
The letter cited numerous violations of good manufacturing processes (GMP). In the area of sanitation, the FDA identified that the firm “failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and keep(ing) them free of infestation by rodents, birds, insects, and other vermin.” They also cited significant mold growth near a sterile manufacturing area, as well as “the ceiling of this room had been allowed to deteriorate to such an extent that it caved in. This room shares a common mezzanine with the adjacent sterile processing rooms.”
The report also found many dead insects in the “Sample Pass Through” Room, which was close to the Sterile Filling Line of “the small volume parenterals facility. In addition, dead and decaying frogs were found next to the product exit dock.”
The FDA also found numerous problems with records and data filing, stating, “Your firm failed to prepare batch production and control records for each batch of drug product that include documentation of each significant step in the manufacture, processing, packaging, or holding of the batch.” They also found unofficial visual inspection records that didn’t match official records in the company’s quality unit, that the company used “scratch paper” with critical manufacturing data that didn’t always match the official records.
Apparently FDA inspectors interviewed Amanta employees who admitted to falsifying records. “Specifically, [Marck’s] head of production reported to our investigator that he completed ‘in process quality assurance check’ fields in the batch record but does not actually perform the listed operations.”
The FDA made six recommendations for the company’s data integrity expert, including identifying that all the cases where “unofficial and scratch paper records” have been used, interview current and former employees to identify the systems and processes that led to the inaccurate data reporting, and identifying the managers who participated in this. The FDA also recommended the company hire a third-party auditor to ensure compliance.
This is at least the twelfth time the FDA has sent a Warning Letter to this pharmaceutical manufacturer on these issues. Amanta manufactures medications for eye care and respiratory drugs, and also acts as a contractor for other facilities. A spokesman for the company, DC Tak, said that the U.S. media was unfairly comparing the company with other Indian drug makers including Sun Pharmaceuticals, Wockhardt, and Ranbaxy, which have also received warnings from the FDA. “We don’t understand why we have been added to this list,” he said, suggesting the company is being “victimized as part of a media witch-hunt.”
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