FDA Inspection
BMR MEDICALBMR MEDICAL – FDA Inspection, Jun 1, 2018
Record Details
This FDA Inspection record concerns BMR MEDICAL, with an inspection on June 1, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · bd94b95c-9b97-4f9e-8d0c-ea75bf8ecd4e
Inspection Facts
- Inspection number
- 1056952
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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