FDA Inspection
Corentec Co., LTDCorentec Co., LTD – FDA Inspection, Aug 29, 2024
Record Details
This FDA Inspection record concerns Corentec Co., LTD, with an inspection on August 29, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bb92a8c2-0f5e-4bd5-a1f5-b7eab41ad8f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1243031
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Corentec Co., LTD
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 19, 2017 | Not classified | Office of Inspections and Investigations | |
| April 9, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 16, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Corentec Co., LTD
- FDA Inspection 1110015 - 2019-10-31
- FDA Inspection 1009769 - 2017-04-19
- FDA Inspection 924849 - 2015-04-09
- FDA Inspection 867451 - 2014-01-16
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