FDA Inspection
Brace AlignBrace Align – FDA Inspection, Mar 29, 2024
Record Details
This FDA Inspection record concerns Brace Align, with an inspection on March 29, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1db23240-242f-4520-a470-192f10bc3410
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1234615
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR 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 820.50Purchasing controls, Lack of or inadequate procedures
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