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Montefiore Medical Center FDA Inspection Record

FEI 2472396 · Inspections, Form 483s, warning letters and import refusals

Montefiore Medical Center is an FDA-inspected facility (FEI 2472396) located in Bronx, NY, US. RegDataLab tracks 7 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 29, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (5 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
1 in FDA's reading room

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 29, 2025Voluntary Action Indicated (VAI)Required records (21 CFR 606.160(b))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Maintenance - tracing (21 CFR 600.12(a))
May 18, 2023Voluntary Action Indicated (VAI)Concurrent documentation (21 CFR 606.160(a)(1))
Qualifications of responsible personnel (21 CFR 606.20(b))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Feb 25, 2019No Action Indicated (NAI)No citations listed
Nov 9, 2016No Action Indicated (NAI)No citations listed
May 20, 2014Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Jun 18, 2012Voluntary Action Indicated (VAI)Legibility and indelibility (21 CFR 606.160(a)(1))
Clean & orderly (21 CFR 606.40)
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Dec 22, 2009Voluntary Action Indicated (VAI)Required records (21 CFR 606.160(b))
Equipment observed, standardized, calibrated (21 CFR 606.60(a))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Notification (21 CFR 630.40(a))
and 1 more

Form 483s and inspection documents

  • 483 on FDA.gov
    Inspection Apr 21, 2025 to Apr 29, 2025, issued Apr 29, 2025 (dates printed on the document). FDA listing date Apr 29, 2025. Published by FDA Oct 26, 2026.

Facility details

Company
Montefiore Medical Center
Location
Bronx, NY (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.