FDA Inspection
BAK KOHLER Medical KGBAK KOHLER Medical KG – FDA Inspection, Jan 19, 2012
Record Details
This FDA Inspection record concerns BAK KOHLER Medical KG, with an inspection on January 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BAK KOHLER Medical KG
- Inspection Date
- January 19, 2012
- Product Type
- Devices
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ID · be8455d1-88bd-41fa-9a60-f9f6f6c96070
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 768246
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(e)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of BAK KOHLER Medical KG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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