FDA Inspection
PatientSafeSolutions, Inc.PatientSafeSolutions, Inc. – FDA Inspection, Sep 20, 2013
Record Details
This FDA Inspection record concerns PatientSafeSolutions, Inc., with an inspection on September 20, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- PatientSafeSolutions, Inc.
- Inspection Date
- September 20, 2013
- Product Type
- Biologics
View Company Profile
ID · 3d93e0d9-9194-4125-9f2c-c4b5b542de31
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 850157
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PatientSafeSolutions, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for PatientSafeSolutions, Inc.
- FDA Inspection 1106733 - 2019-08-29
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