FDA Inspection 863164 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on January 23, 2014 in Cleveland, MS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 23, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cleveland, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |