FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, Oct 10, 2018
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on October 10, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 8533b922-270b-487b-8b85-0b4f43257066
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068299
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Octapharma Plasma, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2016 | Not classified | Dallas District Office | |
| November 16, 2016 | Not classified | Dallas District Office |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1000479 - 2016-11-16
- FDA Inspection 993051 - 2016-11-16
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