FDA Inspection
Immucor, Inc.Immucor, Inc. – FDA Inspection, Feb 20, 2025
Record Details
This FDA Inspection record concerns Immucor, Inc., with an inspection on February 20, 2025, issued by the Atlanta District Office, covering biologics.
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ID · 999ec307-a65f-46f3-8027-58d27e6cf0da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1261762
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Immucor, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2021 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 17, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 20, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 10, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 24, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Immucor, Inc.
- FDA Inspection 1152934 - 2021-07-30
- FDA Inspection 1032394 - 2017-11-17
- FDA Inspection 952012 - 2015-11-20
- FDA Inspection 861759 - 2013-12-10
- FDA Inspection 793764 - 2012-07-24
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