FDA Inspection
Fetzer Medical GmbH & Co. KGFetzer Medical GmbH & Co. KG – FDA Inspection, Sep 27, 2018
Record Details
This FDA Inspection record concerns Fetzer Medical GmbH & Co. KG, with an inspection on September 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2057e9e6-daa7-4bc5-9050-859e78fb1784
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066868
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Fetzer Medical GmbH & Co. KG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 3, 2025 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
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