Northwell Health Fertility NYC FDA Record

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

  • Latest inspection NAI · Mar 19, 2024
  • No warning letters matched by name
Inspections 2 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Northwell Health Fertility NYC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Northwell Health Fertility NYC" is on file.

What these totals cover: FDA records filed under the name "Northwell Health Fertility NYC".

Latest inspection
Mar 19, 2024 · 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
Inspections2Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Northwell Health Fertility NYC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Northwell Health Fertility NYC: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202300000
202200000
202110000
202000000
201900000
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

2 inspections from Sep 22, 2021 to Mar 19, 2024.

DateSiteProductClassificationFEI
Mar 19, 2024New York, NYBiologicsNo Action Indicated (NAI)3015042190
Sep 22, 2021New York, NYBiologicsNo Action Indicated (NAI)3015042190
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 3015042190New York, NY2Mar 19, 2024

Northwell Health Fertility NYC and the FDA: common questions

Has Northwell Health Fertility NYC received an FDA warning letter?

No FDA warning letter addressed to the name "Northwell Health Fertility NYC" 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 Northwell Health Fertility NYC received an FDA Form 483?

FDA has not published a Form 483 for "Northwell Health Fertility NYC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Northwell Health Fertility NYC?

The most recent FDA inspection on file ended Mar 19, 2024 at New York, NY and was classified NAI. FDA has 2 inspections of Northwell Health Fertility NYC on file.

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