FDA Inspection
Banco de Sangre ASEMBanco de Sangre ASEM – FDA Inspection, Jun 22, 2017
Record Details
This FDA Inspection record concerns Banco de Sangre ASEM, with an inspection on June 22, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 4442d200-9142-4cd7-b261-858ed1f7d7fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015511
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.100(b)SOPs for investigations, records
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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 5, 2019 | 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 1092776 - 2019-06-05
- FDA Inspection 924006 - 2015-04-22
- FDA Inspection 859615 - 2013-11-22
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