FDA WARNING_LETTER - Laboratorios Quantium Llc - August 02, 2018

The FDA inspected Laboratorios Quantium LLC in Medley, Florida, from May 16 to August 2, 2018, identifying significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211) and an unapproved new drug violation. The drug product, "Valtrum Soothing Topical Analgesic Ointment," was deemed adulterated and an unapproved new drug under sections 501(a)(2)(B) and 505(a) of the FD&C Act, respectively. CGMP violations included the firm's failure to establish an adequate quality control unit with proper authority and procedures (21 CFR 211.22(a), (d)), failure to test components before use (21 CFR 211.84(a)), inadequate cleaning and maintenance of equipment (21 CFR 211.67(a)), lack of written procedures for production and process control, including process validation (21 CFR 211.100(a)), and failure to support drug product expiration dates with appropriate stability testing (21 CFR 211.137(a)). Additionally, Valtrum was cited as an unapproved new drug because its camphor dosage (2.5%) is inconsistent with the Tentative Final Monograph for External Analgesic Drug Products, and there's no scientific evidence of its general recognition as safe and effective. Some labeled inactive ingredients are also not in FDA's database. The FDA requires the firm to promptly correct all violations, investigate root causes, and prevent recurrence. A written response detailing corrective actions and timelines is due within 15 working days. Failure to comply may result in legal action, including seizure and injunction, and could impact drug application approvals or export certificates. The FDA strongly recommended engaging a qualified CGMP consultant.