FDA 483 - DAP Pharmaceuticals, LLC - September 11, 2019

During an inspection conducted on September 9 and 11, 2019, the U.S. Food and Drug Administration (FDA) issued a Form 483 to DAP Pharmaceuticals, LLC, an API repacker located in Lake Park, FL. The inspection revealed eight significant observations indicating deviations from current Good Manufacturing Practice (cGMP) regulations, which are mandated under the Federal Food, Drug, and Cosmetic Act. Key deficiencies included a failure to maintain stability data to support retest or expiry dates for repackaged Active Pharmaceutical Ingredients (APIs) and inadequate testing of incoming materials, as well as a lack of supplier qualification. The company also lacked essential master production and control records for each API batch and failed to establish written procedures for the receipt and release of packaging and labeling materials. Furthermore, DAP Pharmaceuticals, LLC did not consistently provide customers with the manufacturer’s Certificate of Analysis for repackaged APIs. The quality unit was found not to be independent of production, with the same employees performing both repackaging and batch release. Deficiencies in employee training procedures and a lack of evidence for the effectiveness of cleaning and sanitization methods for equipment were also noted. The company is expected to address these observations by implementing appropriate corrective actions to ensure compliance with regulatory standards.