Agora EdgeDecember 14, 2022

FDA 483 - Agora Edge - December 14, 2022

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Record Details

An FDA inspection of Agora Edge, a contract manufacturer in Saint Petersburg, FL, revealed a significant deficiency in their quality system. The firm failed to adequately establish procedures for the acceptance of raw materials from suppliers. This indicates a moderate concern regarding the control of incoming materials used in manufacturing.

Company: Agora Edge
Inspection Date: December 14, 2022
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
Person: Gisselle I. Sensebe

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ID · 15466036-37a2-4dda-bd38-1ac5c00ad6d2