FDA Inspection
Octapharma Plasma IncOctapharma Plasma Inc – FDA Inspection, Apr 12, 2013
Record Details
This FDA Inspection record concerns Octapharma Plasma Inc, with an inspection on April 12, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma Inc
- Inspection Date
- April 12, 2013
- Product Type
- Biologics
View Company Profile
ID · 5c17b9fe-0ce2-4c24-93d7-3432101ad0e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 827645
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 606.40Clean & orderly
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Octapharma Plasma Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | Not classified | Los Angeles District Office | |
| June 9, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 5, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 30, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma Inc
- FDA Inspection 1252471 - 2025-01-16
- FDA Inspection 1017592 - 2017-06-09
- FDA Inspection 937941 - 2015-08-05
- FDA Inspection 685909 - 2010-09-30
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