FDA WARNING_LETTER - Clean Solutions LLC - May 10, 2024

The FDA issued a Warning Letter to Clean Solutions LLC following an inspection from May 6-10, 2024, 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). The firm's May 29, 2024, response to the FDA 483 was deemed inadequate due to insufficient documentation and evidence of corrective actions. Key violations include failure to conduct identity testing for drug product components and validate supplier analyses (21 CFR 211.84(d)(1), 211.84(d)(2)), and failure to perform appropriate laboratory testing on finished drug products, such as hand sanitizers and antibacterial hand soaps, for conformance to specifications and microbiological purity prior to release (21 CFR 211.165(a), 211.165(b)). Additionally, the firm failed to establish written procedures for production and process control, including process validation and equipment qualification (21 CFR 211.100(a)). The Quality Control Unit also failed to provide adequate oversight, neglecting complaint handling, change control, employee training, stability programs, annual product reviews, equipment cleaning/validation, and batch records (21 CFR 211.22 and others). The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist in achieving compliance. The firm must respond within 15 working days, detailing corrective actions and prevention plans, or face potential regulatory actions including seizure, injunction, and denial of approvals.