FDA Inspection
Gereonics IncGereonics Inc – FDA Inspection, Nov 14, 2014
Record Details
This FDA Inspection record concerns Gereonics Inc, with an inspection on November 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gereonics Inc
- Inspection Date
- November 14, 2014
- Product Type
- Devices
View Company Profile
ID · 551ee2a9-e3fd-44fe-a30c-2e3f5ba05c30
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906756
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 820.184DHR content
- 21 CFR 211.166(a)Lack of written stability program
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