FDA Inspection 1075479 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on December 21, 2018 in Jayuya, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 21, 2018
- Fiscal Year
- 2019
- 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 |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |