FDA Inspection
McRoberts B.V.McRoberts B.V. – FDA Inspection, Aug 28, 2019
Record Details
This FDA Inspection record concerns McRoberts B.V., with an inspection on August 28, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Shaquenta Y. Perkins (Issuing Officer)
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ID · 2a8600d2-7c24-418b-ab2f-9d44b75bc678
Inspection Facts
- Inspection number
- 1101659
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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