FDA Inspection
New Era Orthopaedics, LLcNew Era Orthopaedics, LLc – FDA Inspection, Jun 11, 2018
Record Details
This FDA Inspection record concerns New Era Orthopaedics, LLc, with an inspection on June 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c51288ee-c51f-400d-842f-9e5fa970c574
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056379
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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