FDA Inspection
Mi Gwang Contact Lens Co., Ltd.Mi Gwang Contact Lens Co., Ltd. – FDA Inspection, Jul 5, 2012
Record Details
This FDA Inspection record concerns Mi Gwang Contact Lens Co., Ltd., with an inspection on July 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 5, 2012
- Product Type
- Devices
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ID · bacfb98a-2347-4003-ae59-c2b3ed20a7e4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 790547
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Mi Gwang Contact Lens Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 8, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 19, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mi Gwang Contact Lens Co., Ltd.
- FDA Inspection 1193124 - 2022-12-15
- FDA Inspection 1047085 - 2018-03-08
- FDA Inspection 929308 - 2015-03-19
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