FDA Inspection
Autocam Medical Devices, LLCAutocam Medical Devices, LLC – FDA Inspection, Oct 22, 2025
Record Details
This FDA Inspection record concerns Autocam Medical Devices, LLC, with an inspection on October 22, 2025, issued by the New England District Office, covering medical devices & rad health.
- Company
- Autocam Medical Devices, LLC
- Inspection Date
- October 22, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · eb421261-3e53-4566-a61e-8cd387bb8005
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1290184
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Autocam Medical Devices, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Autocam Medical Devices, LLC
- FDA Inspection 1055436 - 2018-05-18
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