Golden State Medical Supply, Inc. – FDA Warning Letter, Feb 2, 2011

On April 26, 2011, the FDA issued a Warning Letter to Golden State Medical Supply, Inc. following an inspection from January 19 to February 2, 2011. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm's February 25, 2011, response to the FDA 483 was not considered due to late submission.

Key violations include: 1. **Inadequate Investigations (21 CFR § 211.192):** The firm failed to thoroughly investigate discolored Clorazepate Dipotassium tablets (November-December 2010 complaints), not addressing suggested root causes (e.g., container headspace), implementing corrective actions, or evaluating other affected batches. They continued using containers with a different headspace despite manufacturer warnings. Additionally, no investigations were conducted for annual product review deviations, including discolored retain tablets (Paroxetine, Ranitidine, Trazodone), missing desiccants, and "bad" or missing seals on retain products, a repeat observation. 2. **Lack of Stability Testing Program (21 CFR § 211.166(a)):** No written program existed to assess drug product stability, determine storage conditions, or expiration