Capricorn Pharma, Inc. – FDA Warning Letter, Oct 13, 2009

On April 20, 2010, the FDA issued a Warning Letter to Capricorn Pharma, Inc. following an inspection from September 15 to October 13, 2009. 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 October 27, 2009, response was deemed insufficient.

Key violations included: 1. **Failure to establish an appropriate written stability testing program (21 CFR § 211.166(a))**: Products like Guaifenesin Flashbeads were released and distributed without adequate stability data to support labeled expiry periods. This was a repeat observation from a 2008 inspection. 2. **Failure to validate manufacturing processes and reject out-of-specification (OOS) material (21 CFR § 211.110(a), (c))**: During process validation and routine manufacturing, tablets with OOS hardness were not rejected. The firm's justification regarding average specifications was deemed unacceptable, and contradictory statements in their SOP were noted. This was also a repeat observation. 3. **Failure to thoroughly investigate OOS results (21 CFR § 211.192)**: OOS results during process validation were not investigated.