FDA 483 - Impax Laboratories, LLC. - May 04, 2016

Impax Laboratories, Inc. in Hayward, CA, was inspected regarding its manufacturing and post-marketing adverse drug experience processes. The inspection revealed significant deficiencies in equipment cleaning validation and monitoring, as well as a lack of adequate written procedures and record-keeping for adverse drug experience reporting and review. These issues indicate potential risks to drug product quality and patient safety.