FDA WARNING_LETTER - terry yon & associates, inc./ - November 18, 2009

On May 12, 2010, the FDA issued a Warning Letter to Terry Yon & Associates, Inc. dba TYA Pharmaceuticals following a November 16-18, 2009 inspection. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's December 7, 2009 response was deemed insufficient.

Key violations included: 1. **Failure to establish separate or defined manufacturing areas (21 CFR § 211.42(c)(5)) and separate facilities for penicillin operations (21 CFR § 211.42(d)).** The firm repackaged penicillin (e.g., amoxicillin) and non-penicillin beta-lactam (e.g., cephalexin) products in the same hooded cabinet within a single laminar air-flow room. This was a repeat observation from a February 2007 inspection, and the firm's assurance of discontinuing penicillin repackaging was deemed inadequate due to past non-compliance. 2. **Failure to test non-penicillin drug products for penicillin cross-contamination (21 CFR § 211.176).** Despite