FDA Inspection
Mi Gwang Contact Lens Co., Ltd.Mi Gwang Contact Lens Co., Ltd. – FDA Inspection, Dec 15, 2022
Record Details
This FDA Inspection record concerns Mi Gwang Contact Lens Co., Ltd., with an inspection on December 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 15, 2022
- Product Type
- Devices
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ID · 960ca9af-28a9-458d-9e69-3945db16bd6e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1193124
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.70(f)Buildings
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.120(b)Labeling inspection - UDI
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Mi Gwang Contact Lens Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| July 5, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Mi Gwang Contact Lens Co., Ltd.
- FDA Inspection 1047085 - 2018-03-08
- FDA Inspection 929308 - 2015-03-19
- FDA Inspection 790547 - 2012-07-05
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