FDA Inspection
Banco Vida Corp.Banco Vida Corp. – FDA Inspection, Sep 18, 2019
Record Details
This FDA Inspection record concerns Banco Vida Corp., with an inspection on September 18, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b7c6b6b6-81a9-45ca-93ab-50970e27ba52
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1102161
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
4- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Banco Vida Corp.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 12, 2021 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 7, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 1, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Banco Vida Corp.
- FDA Inspection 1337074 - 2026-09-16
- FDA Inspection 1149817 - 2021-08-12
- FDA Inspection 1036677 - 2017-12-07
- FDA Inspection 980721 - 2016-07-01
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