FDA Inspection 1101080 — CSL Plasma Inc.
The FDA completed an inspection of CSL Plasma Inc. on Aug 30, 2019 in Mechanicsburg, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 30, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Mechanicsburg, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 18074 | 21 CFR 630.10(c) | Donor Eligibility on day of donation |
| 18080 | 21 CFR 630.10(e) | Medical History Interview |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |