FDA Inspection
BAK KOHLER Medical KGBAK KOHLER Medical KG – FDA Inspection, Sep 27, 2018
Record Details
This FDA Inspection record concerns BAK KOHLER Medical KG, with an inspection on September 27, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- BAK KOHLER Medical KG
- Inspection Date
- September 27, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · b3b69890-7f75-4d80-a017-deba07538397
Inspection Facts
- Inspection number
- 1066877
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of BAK KOHLER Medical KG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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