Caraco Pharmaceutical Laboratories, LTD. – FDA 483, May 12, 2009

This FDA Form 483 was issued to Caraco Pharmaceutical Laboratories, Ltd. in Detroit, MI, on May 12, 2009, following an inspection. The document outlines 18 observations regarding deviations from current Good Manufacturing Practices (cGMP).

Key violations include: - **Inadequate Record Keeping:** Failure to maintain individual inventory records for component reconciliation, leading to 1.352 Kg of Digoxin USP API and 15 Kg of Metformin HCl API being unaccounted for. Batch production records also lacked complete weight records for dispensed materials (e.g., Digoxin Tablets, Lactose Anhydrous). - **Non-Adherence to Procedures:** Written procedures for raw material storage and handling were not followed, resulting in insufficient quantities of materials and failure to document the return of excess materials (e.g., Paroxetine, Citalopram, Metoprolol, Tramadol, Metformin). - **Insufficient Investigations:** Unexplained discrepancies were not thoroughly reviewed, with investigations (e.g., Incident #0?-005) lacking evidence to support conclusions regarding missing or excess raw materials (e.g., Metoprolol Tartrate, Carbamazepine, Carvedilol, Tramadol HCl). Investigations into missing Digoxin did not extend to other potentially associated drug products. Complaint investigations were incomplete, failing to address health hazard evaluations, out-of-tolerance findings, or root causes (e.g