FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, Sep 24, 2014
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on September 24, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma, Inc.
- Inspection Date
- September 24, 2014
- Product Type
- Biologics
View Company Profile
ID · 4b1c24e3-2d27-4c1c-a5e5-cd92bfa640d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897378
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.171Biological product deviation report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Octapharma Plasma, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 1, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 29, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 24, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1259244 - 2024-12-13
- FDA Inspection 1047796 - 2018-03-01
- FDA Inspection 986379 - 2016-09-29
- FDA Inspection 913736 - 2015-02-10
- FDA Inspection 793025 - 2012-07-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.