Ol Pharma Tech LLC – FDA 483, Jul 22, 2024

During an inspection from July 15-22, 2024, the FDA issued a Form 483 to Ol Pharma Tech LLC, an OTC Human Drug Manufacturer in Madison Heights, MI, citing significant Current Good Manufacturing Practice (CGMP) violations. The company lacked an independent quality control unit, with quality personnel performing production tasks and having no authority over operations. Critical quality unit procedures, including those for recalls, complaints, training, change controls, and out-of-specification investigations, were not established or followed, and existing procedures were often unapproved, unclear, or designed for another firm. Laboratory controls were severely deficient, with no testing for critical contaminants like Burkholderia cepacia in water or finished products, and no impurity testing for raw materials like Propylene Glycol. The firm also failed to routinely test its water system for microorganisms, lacked validated analytical methods, and had inadequate data integrity for laboratory equipment. A comprehensive stability testing program was absent, leading to products being released despite out-of-specification results and uncontrolled storage conditions. Further observations included incomplete and improperly documented batch production records, a complete lack of process validation for drug products, and unqualified manufacturing and laboratory equipment. Cleaning validation was not performed, and the purified water system lacked proper controls, validation, and maintenance. Finally, employee training in specific operations and CGMP was undocumented and lacked approved written procedures. Ol Pharma Tech LLC is required to address these systemic failures to ensure compliance with federal regulations and the safety, identity, strength, quality, and purity of its drug products.