FDA Inspection
Global Pathogen Solutions, IncGlobal Pathogen Solutions, Inc – FDA Inspection, Feb 28, 2012
Record Details
This FDA Inspection record concerns Global Pathogen Solutions, Inc, with an inspection on February 28, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 28, 2012
- Product Type
- Devices
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ID · fda75fb7-7050-4d4d-93e5-d1e44fb8c725
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769768
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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