FDA Inspection 789123 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on Jun 27, 2012 in Cleveland, MS. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 27, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cleveland, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |