FDA Inspection
Pluromed, Inc.Pluromed, Inc. – FDA Inspection, Oct 9, 2012
Record Details
This FDA Inspection record concerns Pluromed, Inc., with an inspection on October 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pluromed, Inc.
- Inspection Date
- October 9, 2012
- Product Type
- Devices
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ID · c33d6c6f-7220-438a-a101-d0eae1a8d165
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810585
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Pluromed, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2011 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 11, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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