FDA Inspection 1177460 — Outin Futures Corp
The FDA completed an inspection of Outin Futures Corp on Aug 12, 2022 in Chungju. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 12, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chungju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |