FDA WARNING_LETTER - Wockhardt, Ltd. - December 15, 2015

The FDA inspected Wockhardt Limited's drug manufacturing facility in Ankleshwar, Gujarat, India, from December 7-15, 2015, identifying significant CGMP violations for finished pharmaceuticals (21 CFR parts 210 and 211) and API deviations. Consequently, the firm's drugs are deemed adulterated under the FD&C Act. Key violations include the failure to establish and follow procedures to prevent microbiological contamination of sterile products, evidenced by airflow disturbances and aseptic technique breaches (21 CFR 211.113(b)). The firm also failed to ensure manufacturing personnel wore appropriate, undamaged clothing (21 CFR 211.28(a)). Laboratory records were incomplete, with unreported OOS results and excluded data (21 CFR 211.194(a)), and 12 computerized systems in the QC lab lacked validation (21 CFR 211.68(b)). Furthermore, activities were not recorded contemporaneously, and original CGMP records were destroyed. The FDA highlighted a systemic failure in data integrity, strongly recommending a qualified consultant for remediation. The firm must provide a detailed response within 15 working days, outlining comprehensive corrective and preventive actions. Business implications include the facility being placed on Import Alert 66-40, potential withholding of new drug application approvals, and continued refusal of admission for products into the U.S.