FDA Inspection 1192582 — UNILAM CO., LTD
The FDA completed an inspection of UNILAM CO., LTD on Dec 8, 2022 in Ulju. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 8, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Ulju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |