FDA 483 - Derma Care Research Labs LLC - September 24, 2019

Perrigo Care Research Laboratories, LLC, a topical OTC drug manufacturer in Daytona Beach, FL, was cited for significant deficiencies during an FDA inspection. Observations included the release of drug products made with out-of-specification water, inadequate data integrity controls, and a lack of essential laboratory and process validations. The firm also failed to demonstrate effective cleaning processes for equipment and proper equipment qualification.