FDA WARNING_LETTER - I Shay Cosmetics Inc - February 29, 2012

On October 22, 2012, the FDA issued a Warning Letter to I. Shay Cosmetics, Inc. following a February 1-29, 2012 inspection of their pharmaceutical manufacturing facility in Gardena, CA. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: * **Inadequate Specifications and Testing (21 C.F.R. § 211.160(b)):** Water testing program is not scientifically sound, potentially masking microbiological contamination. Microbiological testing methods for water and drug products are unvalidated, using inappropriate dilution and culture mediums. Growth promotion tests, antimicrobial effectiveness studies, and preservative content in stability testing are not performed. Colony counts and calculations are not documented. * **Insufficient Production and Process Controls (21 C.F.R. § 211.100(a)):** Manufacturing processes lack scientific evidence of consistent quality. A manufacturing process change for (b)(4) (Lot # (b)(4)) and the addition of an inactive ingredient, "(b)(4)," occurred without quality unit approval or change control. * **Improper Equipment Cleaning and Maintenance (21 C.F.R. § 211.67(a)):**