FDA WARNING_LETTER - LCC Ltd. - March 22, 2024

The FDA issued a Warning Letter to LCC Ltd. following a March 18-22, 2024 inspection, citing significant Current Good Manufacturing Practice (CGMP) violations and the marketing of unapproved and misbranded drug products. The firm's drug products are considered adulterated. CGMP deficiencies include failure to adequately test components for identity, purity, strength, and quality, and to validate supplier test analyses, especially for high-risk components like glycerin, propylene glycol, and (b)(4) for DEG/EG contamination (21 CFR 211.84(d)(1), 211.84(d)(2)). The Quality Control Unit failed to ensure CGMP compliance and product specifications (21 CFR 211.22), and laboratory records lacked complete, trustworthy data, indicating severe data integrity issues (21 CFR 211.194(a)). Additionally, "SOL, Mouthwash, zero alcohol, frosty mint" and "Oriox, Cool Breath, ORAL RINSE, Mild mint" are deemed unapproved new drugs (21 U.S.C. 355(a), 331(d)) as they do not conform to applicable OTC monographs or ANPR conditions. These products are also misbranded (21 U.S.C. 352(ee)) for non-compliance with Section 505G requirements. The FDA noted repeat violations, indicating inadequate executive management oversight. The firm remains on Import Alert 66-40. LCC Ltd. must conduct a full risk assessment for products with high-risk components, implement CAPAs for supply chain security, and undertake comprehensive data integrity remediation, including a third-party audit. If drug manufacturing resumes, a qualified consultant must perform a six-system audit. A response detailing corrective actions is required within 15 working days, with potential consequences including continued import refusal and withheld application approvals.