# FDA 483 - Advanced Machine, Inc - May 02, 2019

Source: https://www.globalkeysolutions.net/records/483/advanced-machine-inc/60243095-52c6-43ff-a542-70632c8ef303

> FDA 483 for Advanced Machine, Inc on May 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Machine, Inc
- Inspection Date: 2019-05-02
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Advanced Machine, Inc. in Winchester, TN, a contract manufacturer, revealed significant deficiencies in their quality management system. Observations included inadequate procedures for equipment calibration, corrective and preventive actions, and customer complaint handling. The firm also failed to adequately maintain records of document changes, indicating systemic issues in their quality processes.

## Related Documents

- [483 - 2025-04-18](https://www.globalkeysolutions.net/records/483/advanced-machine-inc/d9226876-b5f4-4e2c-9ace-fd8e82d475eb)

## Related Officers

- [Mary A. Millner](https://www.globalkeysolutions.net/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

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