FDA Inspection 1196823 — MAXSTAR Industrial Co., Ltd.
The FDA completed an inspection of MAXSTAR Industrial Co., Ltd. on Feb 9, 2023 in Gimpo. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 9, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gimpo (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |