FDA Inspection
Centurion Medical Products, LPCenturion Medical Products, LP – FDA Inspection, Sep 28, 2016
Record Details
This FDA Inspection record concerns Centurion Medical Products, LP, with an inspection on September 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 28, 2016
- Product Type
- Devices
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ID · 9d64ff7e-8409-4a57-ac5d-2e3994bd0451
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987589
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Centurion Medical Products, LP
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 1, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 31, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 18, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 19, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Centurion Medical Products, LP
- FDA Inspection 1199241 - 2023-02-10
- FDA Inspection 1108577 - 2019-11-01
- FDA Inspection 1040471 - 2018-01-31
- FDA Inspection 855596 - 2013-11-18
- FDA Inspection 825194 - 2013-03-19
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