FDA WARNING_LETTER - Caraco Pharmaceutical Laboratories, Ltd - June 11, 2008

An FDA inspection of Caraco Pharmaceutical Laboratories, Ltd.'s Detroit facility from May 1 to June 11, 2008, revealed significant deviations from current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211). These deviations render the drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Key violations include the Quality Control Unit's (QCU) failure to adequately review production records, thoroughly investigate discrepancies like cross-contamination and out-of-specification results (e.g., Tramadol HCl, Metoprolol Tartrate, Metformin HCl contamination, content uniformity, dissolution failures, raw material shortages), and ensure timely closure of incident reports. The QCU also failed to follow written procedures for product release with open investigations and QA Holds, and did not approve or reject procedures impacting drug product quality, such as evaluating changes to manufacturing processes or preventing contamination during dispensing. Further deficiencies involved inadequate component record reconciliation, failure to review and approve changes to established written procedures (e.g., drying time parameters, process change requests), lack of valid in-process specifications for tablets, and insufficient equipment maintenance (e.g., FBD air supply unit). The FDA expressed serious concerns due to the firm's compliance history, repeat violations, the serious nature of observed issues, and potential consumer risk. The company must promptly correct all deficiencies, provide a written response within fifteen working days detailing corrective actions, timelines, and recurrence prevention. Failure to comply may lead to legal action, seizure, injunction, and impact future approvals and contracts.