FDA Inspection
Octapharma Plasma IncOctapharma Plasma Inc – FDA Inspection, Jan 8, 2015
Record Details
This FDA Inspection record concerns Octapharma Plasma Inc, with an inspection on January 8, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma Inc
- Inspection Date
- January 8, 2015
- Product Type
- Biologics
View Company Profile
ID · c074d119-cd27-4242-baa4-9e0f46b6476e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 909240
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Octapharma Plasma Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 24, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 6, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 7, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 28, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma Inc
- FDA Inspection 1153219 - 2021-09-14
- FDA Inspection 1009884 - 2017-03-24
- FDA Inspection 820739 - 2013-02-06
- FDA Inspection 732180 - 2011-06-07
- FDA Inspection 608945 - 2009-08-28
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