FDA 483 - Vitane Pharmaceutical, Inc. - October 23, 2024

Vitane Pharmaceutical, Inc. in Congers, NY, was inspected regarding its drug product repackaging and relabeling operations. The inspection revealed significant deficiencies across multiple areas, including a lack of validated production and process controls, inadequate equipment cleaning validation, insufficient supplier qualification, improper drug product storage conditions, and a failure to conduct annual product reviews. These issues indicate a systemic lack of adherence to quality standards for drug products.