FDA Inspection
Bio-Rad Medical Diagnostics GmbHBio-Rad Medical Diagnostics GmbH – FDA Inspection, Aug 21, 2026
Record Details
This FDA Inspection record concerns Bio-Rad Medical Diagnostics GmbH, with an inspection on August 21, 2026, issued by the Office of Inspections and Investigations, covering biologics.
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ID · 0890eb4c-5402-41a9-93c7-357fda9b2f5f
Inspection Facts
- Inspection number
- 1332862
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 4.2.5Procedures for control of records not documented
- ISO 13485:2016 Clause 7.5.9.1Procedures do not define extent of traceability and records to maintain
- ISO 13485:2016 Clause 8.2.6Evidence of conformity to the acceptance criteria not maintained
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Other FDA inspections of Bio-Rad Medical Diagnostics GmbH
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 6, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 27, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 24, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 2, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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