FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, May 6, 2010
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on May 6, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma, Inc.
- Inspection Date
- May 6, 2010
- Product Type
- Biologics
View Company Profile
ID · 3b66aa40-a402-4396-b814-c5739861456a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 660401
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.65Safe, sanitary, orderly storage
- 21 CFR 606.160(a)(1)Concurrent documentation
- 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 |
|---|---|---|---|
| October 28, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 23, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 23, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 21, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 2, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1191447 - 2022-10-28
- FDA Inspection 1015098 - 2017-05-23
- FDA Inspection 935859 - 2015-07-23
- FDA Inspection 819769 - 2013-02-21
- FDA Inspection 722288 - 2011-05-02
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