# FDA 483 - A.M. Surgical, Inc. - October 20, 2023

Source: https://www.globalkeysolutions.net/records/483/am-surgical-inc/8c8c98a6-a2c5-4bf5-bfc6-6cf0ecbb4f84

> FDA 483 for A.M. Surgical, Inc. on October 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: A.M. Surgical, Inc.
- Inspection Date: 2023-10-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: A.M. Surgical, Inc., a medical device manufacturer in Smithtown, NY, received a Form FDA 483 with one observation. The inspection revealed that the firm's device master record was not adequately maintained. Specifically, it lacked the identification of materials used for manufacturing the devices.

## Related Documents

- [483 - 2021-07-27](https://www.globalkeysolutions.net/records/483/am-surgical-inc/c2ac543f-cf56-46eb-93df-603a86337945)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

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