FDA Inspection
P4X, Inc.P4X, Inc. – FDA Inspection, Mar 29, 2013
Record Details
This FDA Inspection record concerns P4X, Inc., with an inspection on March 29, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- P4X, Inc.
- Inspection Date
- March 29, 2013
- Product Type
- Devices
View Company Profile
ID · c05c722c-ce0e-44dd-b649-90a610fd67c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 824899
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, 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 18, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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