FDA Inspection
Octapharma Plasma IncOctapharma Plasma Inc – FDA Inspection, May 4, 2018
Record Details
This FDA Inspection record concerns Octapharma Plasma Inc, with an inspection on May 4, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a9e02f54-35cc-4f5c-bc3c-31b926113291
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050669
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 640.72(d)Donor reaction
- 21 CFR 640.65(b)(2)(i)Physician review of four month sample
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Octapharma Plasma Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| January 19, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma Inc
- FDA Inspection 1149614 - 2021-07-29
- FDA Inspection 956003 - 2016-01-19
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