Marck Biosiences receives warning letter from USFDA due to GMP violations

Marck Biosciences received a warning letter from the US Food and Drug Administration (USFDA) for violations of current good manufacturing practice (CGMP) regulations at its Kheda plant. In March, the FDA also issued an import alert for products manufactured at the facility into the USA.

FDA investigators identified two maintenance logbooks that included multiple entries describing "significant equipment malfunctions", but for which no investigation into the potential effect on product quality was performed. Inspectors also found "unofficial visual inspection records", signed by production personnel, with data different from the official batch records.

Investigators noted significant mold growth in the washroom located at the entry to the sterile manufacturing area and that the ceiling in there had “partially caved in.” Investigators saw numerous dead insects in the Sample Pass Through Room, near the sterile filling line of a parenterals facility. Additionally, "dead and decaying" frogs were found next to the product exit dock. The investigators found "numerous loose and uncontrolled labels" for multiple products in the open office area adjacent to the packaging lines.