FDA Inspection
Centurion Medical Products, LPCenturion Medical Products, LP – FDA Inspection, Aug 20, 2019
Record Details
This FDA Inspection record concerns Centurion Medical Products, LP, with an inspection on August 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4f0e7f5b-4b22-49b9-8ac5-8c65ffa16022
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1100169
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Centurion Medical Products, LP
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 26, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 29, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Centurion Medical Products, LP
- FDA Inspection 1168643 - 2022-04-05
- FDA Inspection 1061406 - 2018-06-26
- FDA Inspection 944939 - 2015-09-21
- FDA Inspection 919616 - 2015-03-26
- FDA Inspection 790083 - 2012-06-29
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