# FDA 483 - Autocam Medical Devices, LLC - October 22, 2025

Source: https://www.globalkeysolutions.net/records/483/autocam-medical-devices-llc/bf172588-9a3b-46d4-aee6-3987bfcf497a

> FDA 483 for Autocam Medical Devices, LLC on October 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Autocam Medical Devices, LLC
- Inspection Date: 2025-10-22
- Product Type: device
- Office Name: New England District Office
- Summary: Autocam Medical Devices, LLC in Plymouth, MA, a contract manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for corrective and preventive actions (CAPA), insufficient supplier management controls, and failures in complaint handling documentation. These issues indicate systemic problems in ensuring product quality and compliance.

## Related Officers

- [Sunita Pandey](https://www.globalkeysolutions.net/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.globalkeysolutions.net/companies/autocam-medical-devices-llc/93881644-ef58-4b9e-950b-e451c3e4b398

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144