# FDA 483 - Autocam Medical Devices, LLC. - August 01, 2025

Source: https://www.globalkeysolutions.net/records/483/autocam-medical-devices-llc/7cfd85c8-98c8-446f-bb98-a94910c0edf2

> FDA 483 for Autocam Medical Devices, LLC. on August 01, 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: 2025-08-01
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Autocam Medical Devices, LLC. in Kentwood, MI, revealed significant deficiencies in their quality system. Observations included inadequate corrective and preventive action procedures, insufficient monitoring of production processes, and poorly established supplier management requirements. These issues indicate a need for comprehensive improvements in the firm's quality control and documentation practices.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/felicia-e-armbrustmacher/83e0f3f7-2bfc-4250-8627-76685eee6b03)

Company: https://www.globalkeysolutions.net/companies/autocam-medical-devices-llc/878c72ef-567e-48fe-9f64-a8e64c503f7d

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03