FDA Inspection
Octapharma Plasma Inc.Octapharma Plasma Inc. – FDA Inspection, Mar 2, 2017
Record Details
This FDA Inspection record concerns Octapharma Plasma Inc., with an inspection on March 2, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b34ad25c-567f-4cde-86cd-00f5bf6f8a19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003089
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.40Suitable size, construction, etc.
- 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 |
|---|---|---|---|
| April 16, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 9, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 28, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 22, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 29, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma Inc.
- FDA Inspection 1087869 - 2019-04-16
- FDA Inspection 941603 - 2015-09-09
- FDA Inspection 856909 - 2013-10-28
- FDA Inspection 761972 - 2011-12-22
- FDA Inspection 683029 - 2010-09-29
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