FDA WARNING_LETTER - Ranbaxy Laboratories, Ltd., Paonta Sahib, India - March 07, 2008

An FDA inspection of Ranbaxy Laboratories Limited's Batamandi (Unit II) facility in Paonta Sahib, India, from March 3-7, 2008, revealed significant deviations from U.S. Current Good Manufacturing Practice (CGMP) Regulations (21 CFR Parts 210 and 211). These deficiencies render the drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The FDA considers Batamandi (Unit II) part of the existing Paonta Sahib facility, indicating systemic CGMP issues, including a failure of production and quality management, following a previous Warning Letter in 2006 regarding stability testing. Key violations included inaccurate equipment cleaning records where verifying personnel were not present (21 CFR 211.182), incomplete batch production and control records due to absent supervising/checking personnel (21 CFR 211.188(b)(11)), and an SOP allowing manufacturing without an authorized master production record (21 CFR 211.188(a)). Additionally, the Quality Control Unit's review procedures for production records were inadequate, and investigations into discrepancies were not extended to other batches (21 CFR 211.192). The FDA requires a response within 30 days, emphasizing that continued non-compliance will lead to disapproval of new applications and refusal of admission for products, with the exception of Ganciclovir oral capsules due to its sole-source status, subject to third-party verification.