FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, May 24, 2018
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on May 24, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 65b7ba4d-aa0b-45ba-bcd1-a5614d8f6a3a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053924
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 640.64(e)Prevention of contamination
- 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 |
|---|---|---|---|
| March 1, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 10, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 21, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 20, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1230736 - 2024-03-01
- FDA Inspection 947463 - 2015-08-10
- FDA Inspection 824137 - 2013-03-21
- FDA Inspection 824403 - 2013-03-20
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