Engage Uni LLCNovember 12, 2021

FDA 483 - Engage Uni LLC - November 12, 2021

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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.

Company: Engage Uni LLC
Inspection Date: November 12, 2021
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
People: Emma Schaefer (Recall Coordinator)
Brandon P. Thompson

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ID · d50564a6-a374-4848-b47c-8e5d2712084e