# FDA 483 - Advanced Machine, Inc - April 18, 2025

Source: https://www.globalkeysolutions.net/records/483/advanced-machine-inc/d9226876-b5f4-4e2c-9ace-fd8e82d475eb

> FDA 483 for Advanced Machine, Inc on April 18, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Advanced Machine, Inc
- Inspection Date: 2025-04-18
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Advanced Machine, Inc., a contract manufacturer of Class I and Class II unfinished medical devices in Winchester, TN, was cited for significant deficiencies in its quality system. The inspection revealed failures in establishing and following procedures for corrective and preventive actions, device history records, and employee training. Additionally, the firm failed to make required quality records readily available for FDA review.

## Related Documents

- [483 - 2019-05-02](https://www.globalkeysolutions.net/records/483/advanced-machine-inc/60243095-52c6-43ff-a542-70632c8ef303)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/advanced-machine-inc/281eb7f6-0b81-4d0c-be3b-4832fc440c3d

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