# FDA 483 - A.M. Surgical, Inc. - July 27, 2021

Source: https://www.globalkeysolutions.net/records/483/am-surgical-inc/c2ac543f-cf56-46eb-93df-603a86337945

> FDA 483 for A.M. Surgical, Inc. on July 27, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: A.M. Surgical, Inc.
- Inspection Date: 2021-07-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of A.M. Surgical, Inc. in Smithtown, NY, a manufacturer and importer of Class II medical devices, revealed significant deficiencies in its quality system. Observations included inadequate control over contract manufacturers, poorly defined supplier requirements, and insufficient procedures for design changes and product release. The firm also lacked established statistical techniques for process and product characteristic verification.

## Related Documents

- [483 - 2023-10-20](https://www.globalkeysolutions.net/records/483/am-surgical-inc/8c8c98a6-a2c5-4bf5-bfc6-6cf0ecbb4f84)

## Related Officers

- [Jacqueline S. Warner](https://www.globalkeysolutions.net/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.globalkeysolutions.net/companies/am-surgical-inc/18fb0bcb-3aed-4716-8857-2696b19ef6f1

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