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

An FDA inspection of DAP Pharmaceuticals, LLC in Lake Park, FL, an API repacker, revealed significant deficiencies in its quality system. The firm failed to ensure proper stability data, identity testing, record-keeping, and established procedures for packaging and labeling materials. Additionally, issues were noted with the independence of the quality unit, employee training, and the effectiveness of cleaning and sanitization methods.