FDA Inspection 1193124 — Mi Gwang Contact Lens Co., Ltd.
The FDA completed an inspection of Mi Gwang Contact Lens Co., Ltd. on Dec 15, 2022 in Gyeongsan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gyeongsan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3159 | 21 CFR 820.184 | DHR content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |