FDA Inspection
Octapharma Plasma IncOctapharma Plasma Inc – FDA Inspection, May 29, 2009
Record Details
This FDA Inspection record concerns Octapharma Plasma Inc, with an inspection on May 29, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma Inc
- Inspection Date
- May 29, 2009
- Product Type
- Biologics
View Company Profile
ID · eedbcb2d-9605-4d3f-b642-e0f843310831
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 588676
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 640.65(b)(8)Timing
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 640.63(a)Determining donor suitability
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Octapharma Plasma Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2026 | Not classified | Kansas City District Office | |
| September 23, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 16, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 5, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 15, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma Inc
- FDA Inspection 1322600 - 2026-05-15
- FDA Inspection 1153683 - 2021-09-23
- FDA Inspection 1008990 - 2017-03-16
- FDA Inspection 916482 - 2015-03-05
- FDA Inspection 757171 - 2011-12-15
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