FDA Inspection
Octapharma Plasma IncOctapharma Plasma Inc – FDA Inspection, Jan 19, 2016
Record Details
This FDA Inspection record concerns Octapharma Plasma Inc, with an inspection on January 19, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma Inc
- Inspection Date
- January 19, 2016
- Product Type
- Biologics
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ID · 2c3ae100-3938-4970-874c-98dec7a7f87a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 956003
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.67Laboratory tests
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| May 4, 2018 | 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 1050669 - 2018-05-04
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