Banco Vida Corp.September 18, 2019

FDA 483 - Banco Vida Corp. - September 18, 2019

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Banco Vida Corp.

Record Details

Banco Vida Corp. in San Juan, PR, received a Form 483 with four observations related to deficiencies in donor screening and testing for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to adequately screen donors for communicable disease risk factors, including ZIKV and Creutzfeldt-Jacob Disease (CJD), and lacked proper procedures for donor eligibility determination. Additionally, the firm used an uncleared test for syphilis screening.

Company: Banco Vida Corp.
Inspection Date: September 18, 2019
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East IV
People: Annette Melendez
Irina Gaberman (Investigator)

Open in Dashboard

ID · e1632579-f12c-43e0-9526-55c89ccc4ede