FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, May 9, 2019
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on May 9, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f87985e4-a3e3-46b7-b8b5-fedd7caade3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089185
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 630.15(b)(6)RBC loss deferral
- 21 CFR 610.46(a)(2)Supplemental Test for HIV [Collecting Establishment]
- 21 CFR 630.30(b)(1)Unsuitable donation - release
- 21 CFR 640.69(b)Storage temperature for plasma for Injectable products
- 21 CFR 610.41Donor Deferral - reentry
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Octapharma Plasma, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 11, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 31, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1018343 - 2017-03-01
- FDA Inspection 913755 - 2015-02-11
- FDA Inspection 853429 - 2013-10-31
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