FDA Inspection 1089185 — Octapharma Plasma, Inc.
The FDA completed an inspection of Octapharma Plasma, Inc. on May 9, 2019 in Garland, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 9, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Garland, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 15068 | 21 CFR 610.46(a)(2) | Supplemental Test for HIV [Collecting Establishment] |
| 18111 | 21 CFR 630.15(b)(6) | RBC loss deferral |
| 18118 | 21 CFR 630.30(b)(1) | Unsuitable donation - release |
| 355 | 21 CFR 640.69(b) | Storage temperature for plasma for Injectable products |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9271 | 21 CFR 610.41 | Donor Deferral - reentry |