FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, Jan 24, 2012
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on January 24, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma, Inc.
- Inspection Date
- January 24, 2012
- Product Type
- Biologics
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ID · b6dea0a6-ebe0-4d5b-8f5a-666e4681e493
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767837
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(c)Thorough investigations
- 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 |
|---|---|---|---|
| August 18, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 22, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 31, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 31, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 26, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1152642 - 2021-08-18
- FDA Inspection 1044209 - 2018-02-22
- FDA Inspection 986835 - 2016-08-31
- FDA Inspection 865407 - 2014-01-31
- FDA Inspection 664473 - 2010-05-26
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