FDA Inspection
Kent Laboratories, Inc.Kent Laboratories, Inc. – FDA Inspection, Jul 28, 2026
Record Details
This FDA Inspection record concerns Kent Laboratories, Inc., with an inspection on July 28, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5da66d00-e439-4d7b-b81a-a0f8cf448296
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1328290
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 8.5.3Preventive action procedures not documented
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Other FDA inspections of Kent Laboratories, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 14, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 21, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kent Laboratories, Inc.
- FDA Inspection 994520 - 2016-12-07
- FDA Inspection 807178 - 2012-11-14
- FDA Inspection 683180 - 2010-09-21
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