FDA Inspection
J.V. Gaff, Inc.J.V. Gaff, Inc. – FDA Inspection, Aug 23, 2012
Record Details
This FDA Inspection record concerns J.V. Gaff, Inc., with an inspection on August 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- J.V. Gaff, Inc.
- Inspection Date
- August 23, 2012
- Product Type
- Devices
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ID · 1564cc05-267f-4451-8d70-af681d84481f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 796005
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of J.V. Gaff, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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