FDA Inspection 1162366 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on Feb 15, 2022 in Dallas, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 15, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |