FDA Inspection
Octapharma Plasma IncOctapharma Plasma Inc – FDA Inspection, Apr 18, 2012
Record Details
This FDA Inspection record concerns Octapharma Plasma Inc, with an inspection on April 18, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma Inc
- Inspection Date
- April 18, 2012
- Product Type
- Biologics
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ID · 4f533af3-0e99-48a1-8df7-ba3188804d1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777497
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Octapharma Plasma Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 28, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 11, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 18, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma Inc
- FDA Inspection 1192283 - 2022-12-01
- FDA Inspection 1036907 - 2017-11-28
- FDA Inspection 959258 - 2016-02-11
- FDA Inspection 887853 - 2014-07-18
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