FDA WARNING_LETTER - Marck Biosciences Ltd. - November 01, 2013

An FDA inspection of Marck Biosciences Ltd.'s pharmaceutical manufacturing facility in Kheda, India, from October 29 to November 1, 2013, revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm's subsequent response was deemed insufficient. Key violations included failure to maintain accurate batch production and control records, evidenced by discrepancies between official and unofficial records, use of scratch paper, and falsified activities. The firm also failed to maintain adequate equipment maintenance records, ensure proper personnel training (including untrained contract employees and falsified training documents), follow storage and warehousing procedures, maintain clean and sanitary facilities (noting mold and pest infestations), and exercise strict control over labeling. The FDA expressed serious concerns about data integrity, requiring a comprehensive corrective action plan, including the engagement of a third-party auditor to investigate data manipulation, audit distribution practices, and review all data submitted to the FDA. Failure to correct these violations may result in the withholding of new application approvals and refusal of admission for products into the U.S. The firm was required to respond within fifteen working days with specific corrective and preventive actions.