Home / Companies / Banco De Sangre Servicios Mutuos, Inc. [Roosevelt]

Banco De Sangre Servicios Mutuos, Inc. [Roosevelt] FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · May 16, 2025
No warning letters matched by name

Inspections 4

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Banco De Sangre Servicios Mutuos, Inc. [Roosevelt] has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Banco De Sangre Servicios Mutuos, Inc. [Roosevelt]" is on file.

What these totals cover: FDA records filed under the name "Banco De Sangre Servicios Mutuos, Inc. [Roosevelt]".

Latest inspection: May 16, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Banco De Sangre Servicios Mutuos, Inc. [Roosevelt]'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Banco De Sangre Servicios Mutuos, Inc. [Roosevelt]: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

4 inspections from May 11, 2017 to May 16, 2025.

Date	Site	Product	Classification	FEI
May 16, 2025	Guaynabo, PR	Biologics	No Action Indicated (NAI)	3011851494
Sep 8, 2023	Guaynabo, PR	Biologics	No Action Indicated (NAI)	3011851494
Feb 8, 2019	Guaynabo, PR	Biologics	No Action Indicated (NAI)	3011851494
May 11, 2017	Guaynabo, PR	Biologics	No Action Indicated (NAI)	3011851494

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3011851494	Guaynabo, PR	4	May 16, 2025

Banco De Sangre Servicios Mutuos, Inc. [Roosevelt] and the FDA: common questions

Has Banco De Sangre Servicios Mutuos, Inc. [Roosevelt] received an FDA warning letter?

No FDA warning letter addressed to the name "Banco De Sangre Servicios Mutuos, Inc. [Roosevelt]" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Banco De Sangre Servicios Mutuos, Inc. [Roosevelt] received an FDA Form 483?

FDA has not published a Form 483 for "Banco De Sangre Servicios Mutuos, Inc. [Roosevelt]" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Banco De Sangre Servicios Mutuos, Inc. [Roosevelt]?

The most recent FDA inspection on file ended May 16, 2025 at Guaynabo, PR and was classified NAI. FDA has 4 inspections of Banco De Sangre Servicios Mutuos, Inc. [Roosevelt] on file.

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