FDA Inspection
Banco de Sangre ASEMBanco de Sangre ASEM – FDA Inspection, Nov 22, 2013
Record Details
This FDA Inspection record concerns Banco de Sangre ASEM, with an inspection on November 22, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Banco de Sangre ASEM
- Inspection Date
- November 22, 2013
- Product Type
- Biologics
View Company Profile
ID · 52c5d76a-3fe7-4eaf-889e-a960c9421476
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859615
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| 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 |
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 1015511 - 2017-06-22
- FDA Inspection 924006 - 2015-04-22
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