483
Unit Dose Services, LLCUnit Dose Services, LLC – FDA 483, Jan 31, 2020
Record Details
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.
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ID · 63fe7b15-fa64-4315-80f0-6c7bd48c3fce
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