FDA Inspection
Physician Engineered Products, Inc.Physician Engineered Products, Inc. – FDA Inspection, Jun 23, 2015
Record Details
This FDA Inspection record concerns Physician Engineered Products, Inc., with an inspection on June 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 23, 2015
- Product Type
- Devices
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ID · 3e64f85d-c2f6-4ea4-9821-03c0a05c56f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 936480
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design validation - simulated testing
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Other FDA inspections of Physician Engineered Products, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 21, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 9, 2008 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Physician Engineered Products, Inc.
- FDA Inspection 1032554 - 2017-10-20
- FDA Inspection 759924 - 2011-12-21
- FDA Inspection 542242 - 2008-10-09
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