New York University Fertility Center FDA Record

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

  • Latest inspection NAI · Dec 17, 2025
  • No warning letters matched by name
Inspections 7 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

New York University Fertility Center has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "New York University Fertility Center" is on file.

What these totals cover: FDA records filed under the name "New York University Fertility Center".

Latest inspection
Dec 17, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections7Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

New York University Fertility Center: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202310000
202200000
202100000
202000000
201910000
201800000
201700000

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

7 inspections from Jul 17, 2009 to Dec 17, 2025.

DateSiteProductClassificationFEI
Dec 17, 2025New York, NYBiologicsNo Action Indicated (NAI)3004104192
Jun 29, 2023New York, NYBiologicsNo Action Indicated (NAI)3004104192
Sep 17, 2019New York, NYBiologicsNo Action Indicated (NAI)3004104192
Apr 5, 2016New York, NYBiologicsNo Action Indicated (NAI)3004104192
Aug 27, 2014New York, NYBiologicsNo Action Indicated (NAI)3004104192
Jul 24, 2012New York, NYBiologicsNo Action Indicated (NAI)3004104192
Jul 17, 2009New York, NYBiologicsVoluntary Action Indicated (VAI)3004104192
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.

FacilityLocationInspectionsLatest
FEI 3004104192New York, NY7Dec 17, 2025

New York University Fertility Center and the FDA: common questions

Has New York University Fertility Center received an FDA warning letter?

No FDA warning letter addressed to the name "New York University Fertility 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 New York University Fertility Center received an FDA Form 483?

FDA has not published a Form 483 for "New York University Fertility Center" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect New York University Fertility Center?

The most recent FDA inspection on file ended Dec 17, 2025 at New York, NY and was classified NAI. FDA has 7 inspections of New York University Fertility Center on file.

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