FDA WARNING_LETTER - Claris Lifesciences Limited - June 16, 2010

The FDA issued a Warning Letter to Claris Lifesciences Limited (Claris India) and its subsidiary Claris Lifesciences, Inc. (Claris U.S.) following inspections in June 2010 (Claris India), July 2009, and January/February 2010 (Claris U.S.). The inspections revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering drug products adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Inadequate Complaint Investigations (21 CFR § 211.192):** Failure to thoroughly investigate contamination complaints for Metronidazole Injection USP and Ondansetron Injection USP IV bags, lacking scientific justification for root causes (e.g., defective printing stereos, packaging issues) and failing to promptly notify all affected customers. 2. **Insufficient Production and Process Controls (21 CFR § 211.100(a)):** Lack of procedures to evaluate in-process units rejected due to defects, with no documented investigations for significant deviations. 3. **Inadequate Equipment Design and Calibration (21 CFR § 211.63):** Thermocouples used for terminal sterilizer validation were not calibrated before or after cycles, lacking data to support