FDA Inspection
Bumueller GmbHBumueller GmbH – FDA Inspection, Apr 12, 2017
Record Details
This FDA Inspection record concerns Bumueller GmbH, with an inspection on April 12, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 4e5e1ddc-9606-4746-8c39-010e795f7099
Inspection Facts
- Inspection number
- 1014003
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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