# FDA 483 - Antarma LLC - September 23, 2022

Source: https://www.keypedia.com/records/483/antarma-llc/d409c58a-c843-4538-af7e-c582415b192b

> FDA 483 for Antarma LLC on September 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Antarma LLC
- Inspection Date: 2022-09-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/antarma-llc/948a9867-eeb1-4711-b2b1-c2098d8603d7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961