Pharmco Laboratories Inc. – FDA Warning Letter, Nov 30, 2015

On December 15, 2016, the FDA issued a Warning Letter to Pharmco Laboratories, Inc. following an inspection from November 9-30, 2015. The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals (21 CFR Parts 210 and 211) and deviations from CGMP for active pharmaceutical ingredients (API), rendering their drugs adulterated.

Key violations for finished drugs included: 1. Failure to establish adequate written procedures for production and process control, specifically lacking validation for topical OTC drug manufacturing processes and the reverse osmosis purified water system (21 CFR 211.100(a)). 2. Failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods, particularly for in-house assay methods for benzoyl peroxide and salicylic acid (21 CFR 211.165(e)). 3. Failure to establish laboratory controls with scientifically sound specifications, standards, and test procedures, evidenced by a lack of antimicrobial effectiveness data for preservatives in most topical OTC products (21 CFR 211.160(b)). 4. Failure to establish and follow an adequate written stability testing program, with assay methods not indicating stability and insufficient sample testing (21 CFR 211.166(a)).

API deviations included: 1. Failure to demonstrate reproducible manufacturing processes for