FDA Inspection
Centurion Medical Products Corporation, Division of Medline IndustriesCenturion Medical Products Corporation, Division of Medline Industries – FDA Inspection, Mar 22, 2017
Record Details
This FDA Inspection record concerns Centurion Medical Products Corporation, Division of Medline Industries, with an inspection on March 22, 2017, issued by the Denver District Office, covering medical devices & rad health.
- Inspection Date
- March 22, 2017
- Product Type
- Medical Devices & Rad Health
- Office
- Denver District Office
- Person
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ID · 62f7d0a7-60fb-422c-8236-d13e56d3473c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010246
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Centurion Medical Products Corporation, Division of Medline Industries
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 13, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 17, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 30, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Centurion Medical Products Corporation, Division of Medline Industries
- FDA Inspection 1152236 - 2021-08-12
- FDA Inspection 1059548 - 2018-07-13
- FDA Inspection 983064 - 2016-08-17
- FDA Inspection 823313 - 2013-03-14
- FDA Inspection 792471 - 2012-07-30
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