FDA WARNING_LETTER - Sklar Personal Care Inc. - June 09, 2025

The FDA issued a Warning Letter to Sklar Personal Care Inc. following inspections of its Statesville, North Carolina drug manufacturing facility from May 19-23 and June 9, 2025. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated under the Federal Food, Drug, and Cosmetic Act. Key violations include the firm"s failure to adequately test incoming raw materials for identity before use in OTC drug products, specifically neglecting to test certain materials for methanol contamination. This oversight means the firm lacks scientific evidence that its raw materials meet specifications. Additionally, Sklar Personal Care Inc. failed to establish and follow adequate written procedures for equipment cleaning and maintenance, lacking essential cleaning validation studies to prevent contamination. Lastly, the firm failed to establish adequate written procedures for production and process control, specifically neglecting to conduct process validations for its OTC drug products. The company"s responses to these observations were deemed inadequate, lacking comprehensive risk assessments and detailed corrective action plans. The FDA requires Sklar Personal Care Inc. to conduct a thorough review of its material system, implement robust testing for all components, establish detailed cleaning validation protocols, and develop comprehensive process validation for all drug products, including risk assessments for distributed products.