FDA Inspection 963414 — Buckeye International Inc
The FDA completed an inspection of Buckeye International Inc on Jan 12, 2016 in Maryland Heights, MO. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 12, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Maryland Heights, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |