FDA 483 - Unit Dose Services, LLC - January 31, 2020

An FDA inspection of Unit Dose Services, LLC in Dania, FL, revealed significant deficiencies in its quality control unit and cGMP systems. The firm lacked a Quality Manager, failed to investigate out-of-specification data, and did not perform essential quality functions. Additionally, investigation records for discrepancies were incomplete, and critical equipment used in repacking/filling operations lacked qualification, preventative maintenance, and cleaning validation.