FDA Inspection
EFINGER INSTRUMENTS GmbH & Co. KGEFINGER INSTRUMENTS GmbH & Co. KG – FDA Inspection, Feb 9, 2017
Record Details
This FDA Inspection record concerns EFINGER INSTRUMENTS GmbH & Co. KG, with an inspection on February 9, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- February 9, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ea1fc518-3cc8-4a7c-b052-37a03aa49f03
Inspection Facts
- Inspection number
- 1010593
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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