FDA Inspection 1247573 — Model Solution
The FDA completed an inspection of Model Solution on Aug 22, 2024 in Bucheon. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 22, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bucheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |