FDA Inspection
Injex Pharma GmbhInjex Pharma Gmbh – FDA Inspection, Oct 24, 2017
Record Details
This FDA Inspection record concerns Injex Pharma Gmbh, with an inspection on October 24, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · fefdc2ff-f709-495c-84e9-c98743eabe94
Inspection Facts
- Inspection number
- 1031378
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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