FDA Inspection
Dexcowin Co. Ltd.Dexcowin Co. Ltd. – FDA Inspection, Feb 23, 2023
Record Details
This FDA Inspection record concerns Dexcowin Co. Ltd., with an inspection on February 23, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a571b4e4-0815-4213-95b9-80e244338262
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198194
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Dexcowin Co. Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| August 31, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2015 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 3, 2011 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Dexcowin Co. Ltd.
- FDA Inspection 1101231 - 2019-06-06
- FDA Inspection 1024822 - 2017-08-31
- FDA Inspection 921780 - 2015-03-26
- FDA Inspection 732009 - 2011-06-03
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