FDA Inspection
BPC Plasma, Inc.BPC Plasma, Inc. – FDA Inspection, Jun 22, 2018
Record Details
This FDA Inspection record concerns BPC Plasma, Inc., with an inspection on June 22, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 6e902699-2df4-40b8-be41-5572665bc641
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056542
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 630.15(b)(1)(ii)Donor deferral if at risk from procedure
- 21 CFR 630.40(a)Notification
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Other FDA inspections of BPC Plasma, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 29, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 5, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for BPC Plasma, Inc.
- FDA Inspection 950757 - 2015-12-09
- FDA Inspection 789015 - 2012-06-29
- FDA Inspection 655589 - 2010-03-05
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