FDA Inspection 1016876 — Outin Futures Corp
The FDA completed an inspection of Outin Futures Corp on Feb 10, 2017 in Chungju. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 10, 2017
- Fiscal Year
- 2017
- 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |