Company

United States

Banco de Sangre ASEM, San Juan, PR – FDA Inspections

Inspection records and compliance data for Banco de Sangre ASEM in San Juan, Puerto Rico. 9 FDA inspections on record, 2 Form 483s, last inspected September 19, 2025.

Company Profile

This profile covers Banco de Sangre ASEM based in San Juan, Puerto Rico, United States.

FDA Inspection History

FDA inspections: 9
OAI: 0
VAI: 7
NAI: 1
Unclassified: 1
Form 483s: 2
Warning letters: 0

First inspected December 29, 2008. Last inspected September 19, 2025.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs3 inspections
Thorough investigations3 inspections
Person performing, test results, interpretation2 inspections

FDA inspections (9)

Date	Result	FDA center(s)	Insp. #
September 19, 2025	Not classified	Biologics	1284576
June 6, 2023	NAI	Biologics · Blood and Blood Products	1207803
June 5, 2019	VAI	Biologics · Blood and Blood Products	1092776
June 22, 2017	VAI	Biologics · Blood and Blood Products	1015511
April 22, 2015	VAI	Biologics · Blood and Blood Products	924006
November 22, 2013	VAI	Biologics · Blood and Blood Products	859615
November 29, 2011	VAI	Biologics · Blood and Blood Products	755587
March 28, 2011	VAI	Biologics · Blood and Blood Products	718070
December 29, 2008	VAI	Human Drugs · Drug Quality Assurance	559697

FDA documents

Form 483s (1)

Form 483s · June 5, 2019

People (1)

Annette Melendez

Person

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