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•United States

Montefiore Medical Center Blood Bank, Bronx, NY – FDA Inspections

Inspection records and compliance data for Montefiore Medical Center Blood Bank in Bronx, New York. 7 FDA inspections on record, 2 Form 483s, last inspected April 29, 2025.

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Company Profile

This profile covers Montefiore Medical Center Blood Bank based in Bronx, New York, United States.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
5
NAI
2
Form 483s
2
Warning letters
0

First inspected December 22, 2009. Last inspected April 29, 2025.

Most cited issue areas

  • Establish, maintain and follow manufacturing SOPs5 inspections
  • Required records2 inspections
  • Clean & orderly1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
April 29, 2025VAIBiologics · Blood and Blood Products1268343
May 18, 2023VAIBiologics · Blood and Blood Products1205526
February 25, 2019NAIBiologics · Blood and Blood Products1081939
November 9, 2016NAIBiologics · Blood and Blood Products991434
May 20, 2014VAIBiologics · Blood and Blood Products883640
June 18, 2012VAIBiologics · Blood and Blood Products785320
December 22, 2009VAIBiologics · Blood and Blood Products632637
FDA documents

Form 483s (2)

  • Form 483s · April 29, 2025
  • Form 483s · May 18, 2023
People (2)
Amy W. Yan-Mai
Person
Irina Gaberman
Person
Related Companies (10)

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New York Blood Center Enterprises
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Rockefeller Fertility Center
Memorial Hospital For Cancer & Allied Diseases
Skye Biologics Holdings LLC
Lexington Medical Center
Eversight Illinois
Texoma Regional Blood Center
Nemours Alfred I. duPont Hospital for Children
Huntington Reproductive Center Medical Group
Company Information

Name

Montefiore Medical Center Blood Bank

FEI Number

2472396

Address

111 E 210th St, Bronx, New York 10467, United States

Country

United States

ID: 7033c869-0208-41d0-9a7a-2ea327dba84a

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