FDA Inspection 1069929 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on October 24, 2018 in Guayama, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 24, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Guayama, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |