Choksi Laboratory – FDA Warning Letter, Apr 24, 2010

On September 30, 2010, the FDA issued a Warning Letter to Choksi Laboratories, Ltd. following an inspection from April 21-24, 2010, at their Panchkula, Haryana, India facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering drug product components tested by the facility adulterated. The firm did not provide a written response to the FDA-483.

Key violations include: 1. **Lack of Scientifically Sound Procedures (21 CFR § 211.160(b))**: Issues included untraceable gas chromatographic data, missing original chromatograms, non-existent or inadequate in-house laboratory procedures (e.g., for GC and HPLC), destruction of customer-provided test procedures, inadequate sample integrity SOPs, insufficient documentation for tests like loss on drying, and lack of method verification for compendial tests. 2. **Inadequate Out-of-Specification (OOS) Investigations (21 CFR § 211.192)**: The OOS procedure was inappropriate, allowing invalidation of OOS results based on subsequent analyses of new samples without re-analysis of original solutions. OOS investigations were only conducted if clients provided additional payment, and documentation was not maintained for all OOS events.