FDA Inspection
Kerma Medical Products, IncKerma Medical Products, Inc – FDA Inspection, Jan 23, 2014
Record Details
This FDA Inspection record concerns Kerma Medical Products, Inc, with an inspection on January 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kerma Medical Products, Inc
- Inspection Date
- January 23, 2014
- Product Type
- Devices
View Company Profile
ID · 22972682-7e26-40de-ac5b-15f67e82e8d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863395
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Kerma Medical Products, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 7, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 4, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kerma Medical Products, Inc
- FDA Inspection 1024609 - 2017-07-07
- FDA Inspection 752181 - 2011-11-04
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