FDA Inspection
SICAT GMBH & CO. KGSICAT GMBH & CO. KG – FDA Inspection, Sep 7, 2017
Record Details
This FDA Inspection record concerns SICAT GMBH & CO. KG, with an inspection on September 7, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 368c6da1-3c77-4190-b37c-b773975bbb73
Inspection Facts
- Inspection number
- 1024791
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.181DMR - not or inadequately maintained
- 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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