FDA Inspection
HGR Instrumente GmbHHGR Instrumente GmbH – FDA Inspection, Jan 24, 2019
Record Details
This FDA Inspection record concerns HGR Instrumente GmbH, with an inspection on January 24, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 6ee99d06-fe23-41b4-9970-2cd779064bac
Inspection Facts
- Inspection number
- 1078232
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
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