FDA Inspection
Banco de Sangre ASEMBanco de Sangre ASEM – FDA Inspection, Jun 5, 2019
Record Details
This FDA Inspection record concerns Banco de Sangre ASEM, with an inspection on June 5, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · bd097ce1-a0cf-4633-a268-27b94e6f6e01
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092776
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Banco de Sangre ASEM
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2025 | Not classified | San Juan District Office | |
| June 6, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 22, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 22, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 22, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Banco de Sangre ASEM
- FDA Inspection 1284576 - 2025-09-19
- FDA Inspection 1207803 - 2023-06-06
- FDA Inspection 1015511 - 2017-06-22
- FDA Inspection 924006 - 2015-04-22
- FDA Inspection 859615 - 2013-11-22
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