Antarma LLCSeptember 23, 2022

FDA 483 - Antarma LLC - September 23, 2022

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Record Details

Antarma LLC, a specification developer in New York, NY, was inspected by the FDA from September 22-23, 2022. The inspection resulted in one observation regarding inadequate procedures for ensuring purchased products and services conform to specified requirements. Specifically, the firm failed to qualify a contractor performing testing on suture devices and lacked an agreement for supplier change notification.

Company: Antarma LLC
Inspection Date: September 23, 2022
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Colin E. Tack

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ID · d409c58a-c843-4538-af7e-c582415b192b