# FDA 483 - Laboratorio Banco Vida - August 12, 2021

Source: https://www.keypedia.com/records/483/laboratorio-banco-vida/00d64678-5abe-49e8-9280-af7810ee2ef3

> FDA 483 for Laboratorio Banco Vida on August 12, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratorio Banco Vida
- Inspection Date: 2021-08-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Laboratorio Banco Vida in San Juan, PR, a human tissue establishment, was cited for three observations during an FDA inspection. The firm failed to adequately validate processing methods to reduce the risk of communicable disease transmission by HCT/Ps and did not properly investigate deviations related to microbial contamination in umbilical cord blood tissues. Additionally, the firm lacked documented procedures for handling microbial growth and failed to update manufacturing procedures with necessary corrective actions.

## Related Documents

- [483 - 2019-09-18](https://www.keypedia.com/records/483/laboratorio-banco-vida/2731a493-97b8-4b1f-aa58-3460b8ee8f8c)

## Related Officers

- [Laura E. Garcia](https://www.keypedia.com/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)
- [Annette Melendez](https://www.keypedia.com/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)

Company: https://www.keypedia.com/companies/laboratorio-banco-vida/1679ca95-a5b9-49ba-bc80-dccff43d708a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6