FDA Inspection
Fine Surgical Instruments, Inc.Fine Surgical Instruments, Inc. – FDA Inspection, Sep 23, 2009
Record Details
This FDA Inspection record concerns Fine Surgical Instruments, Inc., with an inspection on September 23, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 23, 2009
- Product Type
- Devices
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ID · 2ba5b4e8-f43f-4be0-9e0b-1e32f46c1d49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614771
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(a)General
- 21 CFR 820.40(a)Document locations, Dissemination, etc.
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.75(a)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fine Surgical Instruments, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 29, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 5, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 5, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fine Surgical Instruments, Inc.
- FDA Inspection 968941 - 2016-04-07
- FDA Inspection 965934 - 2015-12-29
- FDA Inspection 834737 - 2013-06-05
- FDA Inspection 721657 - 2011-04-20
- FDA Inspection 645455 - 2010-02-05
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