FDA Inspection 1169330 — Baxter Healthcare Corporation
The FDA completed an inspection of Baxter Healthcare Corporation on May 12, 2022 in Marion, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 12, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Marion, NC (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 |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1956 | 21 CFR 211.180(e)(1) | Representative Number of Batches for Annual Review |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |