FDA Inspection
Psi Health Solutions, Inc.Psi Health Solutions, Inc. – FDA Inspection, Sep 9, 2015
Record Details
This FDA Inspection record concerns Psi Health Solutions, Inc., with an inspection on September 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Psi Health Solutions, Inc.
- Inspection Date
- September 9, 2015
- Product Type
- Devices
View Company Profile
ID · 9918e865-675a-4d82-bd1c-357e011e6cc1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941281
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Psi Health Solutions, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2024 | Not classified | San Francisco District Office | |
| April 13, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 24, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Psi Health Solutions, Inc.
- FDA Inspection 1240182 - 2024-05-14
- FDA Inspection 776811 - 2012-04-13
- FDA Inspection 663354 - 2010-05-24
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