FDA WARNING_LETTER - Huvepharma Inc - February 28, 2013

An FDA inspection of Huvepharma, Inc. in St. Louis, MO, conducted from February 14-28, 2013, revealed significant deviations from Current Good Manufacturing Practice (cGMP) for Type A medicated articles, as per 21 CFR Part 226. These deficiencies cause the firm's products to be adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Key violations included the firm's failure to adhere to established potency specifications for incoming active pharmaceutical ingredients (API), specifically Salinomycin, leading to the use of subpotent material in manufacturing Sacox 60. Additionally, drug component containers were not properly stored to prevent mix-ups and contamination, with rejected API found outside quarantine and a recurring issue with a superpotent recalled lot. Lastly, buildings used for production and storage lacked adequate temperature and humidity controls, resulting in raw materials and finished products being stored outside their labeled ranges, a recurring observation from prior inspections. Huvepharma's March 11, 2013, response to the FDA-483 was acknowledged, with corrective actions to be verified. The FDA requires immediate steps to correct deficiencies and prevent recurrence within 15 working days, including clarifying the root cause of low Salinomycin potency, providing LOD testing results, and potentially revising specifications. Failure to comply may lead to regulatory actions such as seizure or injunction.