FDA Inspection
P4X, Inc.P4X, Inc. – FDA Inspection, Mar 18, 2009
Record Details
This FDA Inspection record concerns P4X, Inc., with an inspection on March 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- P4X, Inc.
- Inspection Date
- March 18, 2009
- Product Type
- Devices
View Company Profile
ID · 2c276365-de30-4db5-b7b8-a57e75a580ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 570916
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of P4X, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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