Yale-New Haven Hospital - York Street Campus FDA Record

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

  • Latest inspection NAI · Aug 22, 2025
  • No warning letters matched by name
Inspections 11 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Yale-New Haven Hospital - York Street Campus has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Yale-New Haven Hospital - York Street Campus" is on file.

What these totals cover: FDA records filed under the name "Yale-New Haven Hospital - York Street Campus".

Latest inspection
Aug 22, 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
Inspections11Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Yale-New Haven Hospital - York Street Campus's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Yale-New Haven Hospital - York Street Campus: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202410000
202300000
202210000
202100000
202000000
201900000
201810000
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

11 inspections from Jan 12, 2010 to Aug 22, 2025.

DateSiteProductClassificationFEI
Aug 22, 2025New Haven, CTBiologicsNo Action Indicated (NAI)1270008
Mar 22, 2024New Haven, CTBiologicsNo Action Indicated (NAI)1270008
Jun 23, 2022New Haven, CTBiologicsNo Action Indicated (NAI)1270008
Aug 17, 2018New Haven, CTBiologicsNo Action Indicated (NAI)1270008
Apr 21, 2016New Haven, CTBiologicsNo Action Indicated (NAI)1270008
Jun 12, 2014New Haven, CTBiologicsVoluntary Action Indicated (VAI)1270008
Mar 12, 2014New Haven, CTBiologicsNo Action Indicated (NAI)1270008
Mar 16, 2012New Haven, CTBiologicsVoluntary Action Indicated (VAI)1270008
Sep 13, 2011New Haven, CTBiologicsNo Action Indicated (NAI)1270008
Apr 20, 2010New Haven, CTBiologicsNo Action Indicated (NAI)1270008
Jan 12, 2010New Haven, CTBiologicsNo Action Indicated (NAI)1270008
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 1270008New Haven, CT11Aug 22, 2025

Yale-New Haven Hospital - York Street Campus and the FDA: common questions

Has Yale-New Haven Hospital - York Street Campus received an FDA warning letter?

No FDA warning letter addressed to the name "Yale-New Haven Hospital - York Street Campus" 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 Yale-New Haven Hospital - York Street Campus received an FDA Form 483?

FDA has not published a Form 483 for "Yale-New Haven Hospital - York Street Campus" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Yale-New Haven Hospital - York Street Campus?

The most recent FDA inspection on file ended Aug 22, 2025 at New Haven, CT and was classified NAI. FDA has 11 inspections of Yale-New Haven Hospital - York Street Campus on file.

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