FDA Inspection
Physio PSPhysio PS – FDA Inspection, Jun 13, 2012
Record Details
This FDA Inspection record concerns Physio PS, with an inspection on June 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Physio PS
- Inspection Date
- June 13, 2012
- Product Type
- Devices
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ID · cbf76ff4-8660-4973-ba28-d073ae6b3163
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 788418
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Physio PS
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 12, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 16, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Physio PS
- FDA Inspection 1293644 - 2025-11-20
- FDA Inspection 1107051 - 2019-06-12
- FDA Inspection 650453 - 2010-02-16
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