Vitane Pharmaceutical, Inc. – FDA 483, Oct 23, 2024

An FDA inspection of Vitane Pharmaceutical, Inc., a drug product repacker and relabeler located in Congers, NY, was conducted from October 15 to October 23, 2024. The inspection revealed five significant observations under the Current Good Manufacturing Practices (cGMP) regulatory framework, highlighting critical deficiencies in the company's operational and quality systems. Major issues included a lack of established written procedures for production and process controls, specifically the absence of packaging process validation studies and equipment qualification for their various packaging lines. The firm also failed to validate its equipment cleaning procedures for shared packaging equipment, raising concerns about potential contamination. Furthermore, Vitane Pharmaceutical, Inc. accepted component supplier analyses without adequately qualifying suppliers or validating their Certificates of Analysis. Drug products were not stored under appropriate temperature conditions, largely due to an inadequate warehouse temperature mapping study that lacked proper protocols, documentation, and continuous monitoring. Lastly, the company had not completed Annual Product Reviews for any of its packaged drug products, which are essential for evaluating quality standards. Vitane Pharmaceutical, Inc. is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure the consistent identity, strength, purity, and quality of its drug products.