FDA WARNING_LETTER - Master Paints & Chemicals Corp. - October 17, 2023

The FDA inspected Master Paints & Chemicals Corp. in Guayanilla, Puerto Rico, from October 11-17, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include the failure to perform appropriate laboratory testing for each drug product batch prior to release (21 CFR 211.165(a)), specifically inadequate potency and microbiological testing for OTC drugs like hand sanitizer and isopropyl alcohol. The firm also failed to conduct at least one identity test for each component of a drug product (21 CFR 211.84(d)(1)), raising concerns about raw material quality, including potential contamination risks from methanol in ethanol and diethylene glycol (DEG)/ethylene glycol (EG) in glycerin. Furthermore, the quality control unit failed to adequately exercise its responsibility to ensure CGMP compliance and meet established specifications (21 CFR 211.22), indicating an ineffective quality system and insufficient oversight of production, process controls, stability programs, and equipment cleaning. The FDA recommends engaging a qualified consultant to evaluate operations and assist with CGMP requirements. The company must provide a detailed response within 15 working days outlining corrective actions, including comprehensive testing plans, risk assessments for distributed products, and a remediation plan for the quality unit. Failure to address these violations may lead to regulatory actions such as seizure, injunction, and withholding of export certificates or new application approvals.