# FDA 483 - Banco de Sangre ASEM - June 05, 2019

Source: https://www.globalkeysolutions.net/records/483/banco-de-sangre-asem/b9ee2a1c-c60e-445e-98b1-a95d8dd2d560

> FDA 483 for Banco de Sangre ASEM on June 05, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Banco de Sangre ASEM
- Inspection Date: 2019-06-05
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Banco de Sangre ASEM, a blood bank establishment in San Juan, PR, revealed a significant issue regarding the investigation and follow-up of adverse donor reactions. The firm failed to complete final conclusions for a substantial number of donor reactions and did not follow up on some of these cases. This indicates a lapse in maintaining proper records and ensuring donor safety protocols.

## Related Officers

- [Annette Melendez](https://www.globalkeysolutions.net/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)

Company: https://www.globalkeysolutions.net/companies/banco-de-sangre-asem/11ab3f50-69cb-48f8-a2e5-91981f56112d

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