483
Engage Uni LLCEngage Uni LLC – FDA 483, Nov 12, 2021
Record Details
Engage Uni LLC, a specification developer and complaint file establishment in Orlando, FL, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for acceptance activities, resulting in undetected out-of-specification products and undocumented deviations. Additionally, the firm lacked adequate procedures for corrective and preventive actions, specifically regarding the trending and evaluation of quality data.
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ID · d50564a6-a374-4848-b47c-8e5d2712084e
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