Montefiore Medical Center FDA Record

Summary

FDA record by year

Montefiore Medical Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

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.

Montefiore Medical Center Form 483s

1 Form 483 published by FDA.

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

8 inspections from Dec 22, 2009 to Apr 29, 2025.

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

2 inspected sites, newest inspection first.

Montefiore Medical Center and the FDA: common questions

Has Montefiore Medical Center received an FDA warning letter?

No FDA warning letter addressed to the name "Montefiore Medical Center" 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 Montefiore Medical Center received an FDA Form 483?

FDA has published 1 Form 483 for Montefiore Medical Center in its reading room, the most recent dated Apr 29, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Montefiore Medical Center?

The most recent FDA inspection on file ended Apr 29, 2025 at Bronx, NY and was classified VAI. FDA has 8 inspections of Montefiore Medical Center on file.