FDA WARNING_LETTER - Aerosol and Liquid Packaging, Inc. - December 18, 2023

The FDA inspected Aerosol and Liquid Packaging, Inc. from December 4-18, 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). The firm, a contract manufacturer of OTC drugs, failed to conduct identity testing for components and validate supplier Certificates of Analysis (21 CFR 211.84(d)(1) and (d)(2)). They also lacked established written procedures for production and process control, including equipment qualification and process validation (21 CFR 211.100(a)), a repeat observation from previous inspections. Further deficiencies included inadequate cleaning, maintenance, and sanitization of shared equipment without cleaning validation (21 CFR 211.67(a)), and a failed quality control unit to ensure CGMP compliance and product specifications (21 CFR 211.22), also a repeat observation. Additionally, their (b)(4) drug product was cited as an unapproved new drug (21 U.S.C. 355(a)) and misbranded (21 U.S.C. 352(ee)). The firm's responses to the FDA 483 were deemed inadequate. FDA recommends engaging a qualified CGMP consultant to conduct a comprehensive six-system audit. Failure to promptly address these violations may lead to regulatory actions, including seizure, injunction, and impact on export certificates or new drug application approvals. A written response detailing corrective actions is required within 15 working days.