FDA Inspection
Gendron Inc.Gendron Inc. – FDA Inspection, Mar 16, 2018
Record Details
This FDA Inspection record concerns Gendron Inc., with an inspection on March 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f3e6ca01-1bd8-43f2-8a2b-62e9c9d97663
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044724
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Gendron Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 11, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gendron Inc.
- FDA Inspection 885340 - 2014-07-02
- FDA Inspection 612343 - 2009-09-11
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