FDA Inspection
DPM USA Corp.DPM USA Corp. – FDA Inspection, Dec 7, 2012
Record Details
This FDA Inspection record concerns DPM USA Corp., with an inspection on December 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DPM USA Corp.
- Inspection Date
- December 7, 2012
- Product Type
- Devices
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ID · c1f8934c-b9d1-456d-8e8b-1afc42492911
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810097
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of DPM USA Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DPM USA Corp.
- FDA Inspection 1052326 - 2018-02-28
- FDA Inspection 896209 - 2014-09-15
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