FDA Inspection 1158970 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on Dec 15, 2021 in South Portland, ME. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 15, 2021
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- South Portland, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |