FDA Inspection
Pori & Rowe Assoc IncPori & Rowe Assoc Inc – FDA Inspection, Mar 26, 2015
Record Details
This FDA Inspection record concerns Pori & Rowe Assoc Inc, with an inspection on March 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pori & Rowe Assoc Inc
- Inspection Date
- March 26, 2015
- Product Type
- Devices
View Company Profile
ID · 97238599-a18f-4516-90b0-003ed426f542
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 919516
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Pori & Rowe Assoc Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Pori & Rowe Assoc Inc
- FDA Inspection 795309 - 2012-08-20
- FDA Inspection 649684 - 2010-02-24
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