FDA Inspection
Corentec Co., LTDCorentec Co., LTD – FDA Inspection, Jan 16, 2014
Record Details
This FDA Inspection record concerns Corentec Co., LTD, with an inspection on January 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Corentec Co., LTD
- Inspection Date
- January 16, 2014
- Product Type
- Devices
View Company Profile
ID · e661e8c2-8aab-4e2b-a2d5-0fcdc635bfcd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867451
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.86Acceptance status
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Corentec Co., LTD
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for Corentec Co., LTD
- FDA Inspection 1243031 - 2024-08-29
- FDA Inspection 1110015 - 2019-10-31
- FDA Inspection 1009769 - 2017-04-19
- FDA Inspection 924849 - 2015-04-09
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