FDA Inspection
Proto Labs Germany GmbHProto Labs Germany GmbH – FDA Inspection, Nov 4, 2022
Record Details
This FDA Inspection record concerns Proto Labs Germany GmbH, with an inspection on November 4, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Proto Labs Germany GmbH
- Inspection Date
- November 4, 2022
- Product Type
- Devices
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ID · f3582a01-a48d-411a-b327-96705b0c7ee2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1190359
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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