FDA Inspection
Psoria Shield, Inc.Psoria Shield, Inc. – FDA Inspection, Aug 23, 2012
Record Details
This FDA Inspection record concerns Psoria Shield, Inc., with an inspection on August 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Psoria Shield, Inc.
- Inspection Date
- August 23, 2012
- Product Type
- Devices
View Company Profile
ID · aacb9f75-ca6e-41e1-9b10-2daa10d6add1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 795561
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 860.7(g)(2)Rpts of safety & effectiveness, adulteration or misbranding
- 21 CFR 803.17(b)(2)Reports and information documentation
- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.30(a)(2)Results of tests
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Other FDA inspections of Psoria Shield, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2025 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 14, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 24, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Psoria Shield, Inc.
- FDA Inspection 1288434 - 2025-10-22
- FDA Inspection 1217701 - 2023-09-14
- FDA Inspection 1023118 - 2017-08-24
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