FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, Oct 19, 2018
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on October 19, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · e7fa7f80-a94f-4df3-83d9-f4c8d5762da0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069222
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.40Clean & orderly
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Octapharma Plasma, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1223733 - 2023-10-20
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.