Alpha Laboratories, Inc. – FDA Warning Letter, Oct 27, 2010

On May 5, 2011, the FDA issued a Warning Letter to Alpha Laboratories, Inc., a contract testing laboratory in Toronto, Canada, following an October 25-27, 2010 inspection. 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 Alpha Laboratories adulterated.

Key violations include: 1. **Inadequate Out-of-Specification (OOS) Investigations (21 CFR § 211.192):** The firm failed to thoroughly investigate OOS results for samples, and OOS results were not recorded in the OOS logbook. The Quality Control Unit approved Certificates of Analysis with OOS results without investigation. The firm's response lacked commitment to a retrospective review of all OOS lots from the last three years. 2. **Failure to Follow Written Procedures for Laboratory Controls (21 CFR § 211.160(a)(b)(3)(4)):** * The OOS procedure (SOP-GEN-0008 Rev 4) was not followed, as re-tests were not performed for OOS samples #542, #545, #546, #521, and reasons for not conducting investigations or notifying clients were not documented.