FDA Inspection 679626 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on August 26, 2010 in Jayuya, PR. 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
- August 26, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jayuya, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |