Warning letter
Banco Vida Corp.: warning letter of Aug 12, 2020
FDA warning letter 606288 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 606288 |
|---|---|
| Company | Banco Vida Corp. |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Aug 12, 2020 |
| Posted date | Aug 25, 2020 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 312, 1271, 1271.15, 1271.3(e), 1271.10(a), 1271.10(a)(4), 1271.75(a)(1), 1271.3(d), 1271.3(r)(2), 1271.75(a), 1271.75(d) |
| Inspection city | San Juan |
| Inspection ZIP | 00918 |
| Inspection start date | Sep 9, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: