# FDA 483 - CryoSurgery, Inc. - March 09, 2023

Source: https://www.keypedia.com/records/483/cryosurgery-inc/d7b9b25f-6691-4ccf-9e58-8e33fa791b5a

> FDA 483 for CryoSurgery, Inc. on March 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CryoSurgery, Inc.
- Inspection Date: 2023-03-09
- Product Type: device
- Office Name: New Orleans District Office
- Summary: CryoSurgery, Inc. in Nashville, TN, was inspected by the FDA from March 6-9, 2023. The inspection revealed two significant observations concerning the lack of established procedures for device history records and inadequate procedures for finished device acceptance. These issues indicate deficiencies in the firm's quality system for manufacturing Class II medical devices.

## Related Officers

- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/cryosurgery-inc/cdc53230-916a-48fc-88c1-6d54e1f71870

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea