FDA Inspection
Diagnostic Grifols, S.A.Diagnostic Grifols, S.A. – FDA Inspection, Feb 16, 2017
Record Details
This FDA Inspection record concerns Diagnostic Grifols, S.A., with an inspection on February 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 64042802-18e9-480f-84ff-b4660e0ee01e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002584
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Diagnostic Grifols, S.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2025 | Not classified | Office of Inspections and Investigations | |
| December 14, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2017 | Not classified | Office of Inspections and Investigations | |
| November 14, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 30, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Diagnostic Grifols, S.A.
- FDA Inspection 1273855 - 2025-05-09
- FDA Inspection 1082479 - 2018-12-14
- FDA Inspection 1031526 - 2017-07-20
- FDA Inspection 1004513 - 2016-11-14
- FDA Inspection 919194 - 2015-01-30
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