Ranbaxy Laboratories, Ltd., Dewas, India – FDA Warning Letter, Feb 12, 2008

This FDA Warning Letter, dated September 16, 2008, was issued to Ranbaxy Laboratories, Ltd., Dewas, India, following an inspection from January 28 - February 12, 2008. The inspection revealed significant deviations from U.S. current Good Manufacturing Practice (CGMP) Regulations (21 CFR Parts 210 and 211) for sterile and non-sterile finished products, and violations of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act for Active Pharmaceutical Ingredients (APIs).

Key violations include: 1. **Inadequate Beta-Lactam Containment Program:** Failure to establish separate areas for non-penicillin beta-lactam products, observed inadequate containment practices (personnel/material movement, record handling), and insufficient decontamination procedures and monitoring programs (lack of testing for penem, penicillin, and cephalosporin residues in various blocks, and no contingency plans for contamination). 2. **Incomplete Batch Production and Control Records:** Records lacked documentation of excipient weights/measures and second-person verification for non-sterile products, and incomplete information for sterile media fill batches (operator initials, visual inspection, integrity tests). 3. **Inadequate Failure Investigations:** Sterility failures for four sterile API batches were inadequately investigated (root cause not confirmed, inaccurate reporting, environmental/personnel monitoring data