During an October-November 2013 inspection of Marck Biosciencies' plant in Kheda, India, the U.S. FDA found several significant and troubling cGMP violations.
FDA inspection revealed “unofficial” visual inspection records, signed by production personnel, with data that differed from the official batch records. In many of the reviewed cases, the "unofficial" records showed significantly more quality defects than the official batch records.
Additionally, interviewed employees admitted to the FDA that batch records had been falsified. According to the FDA Warning letter, "Specifically, your head of production reported to our investigator that he completes 'in process quality assurance check' fields in the batch record but does not actually perform the listed operations."
Investigators also noted dead insects inside the plant, as well as dead and decaying frogs next to the product exit dock. One washroom contained so much mold that the ceiling had caved in. The facility is surrounded by a "swamp-like perimeter" harboring vermin.
The FDA is asking for a detailed corrective action plan as well as expecting Marck to hire a third party auditor to assist with evaluation and overall compliance with cGMP.
Marck, a manufacturer of sterile liquid parenterals, announced on its website that effective June 24, 2014, the company is rebranding itself from Marck Biosciences Ltd. to Amanta Healthcare Ltd.
Read the FDA Warning letter