Hospital For Special Surgery IRB FDA Record

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

Hospital For Special Surgery IRB has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Hospital For Special Surgery IRB" is on file.

What these totals cover: FDA records filed under the name "Hospital For Special Surgery IRB".

Latest inspection
Apr 30, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Hospital For Special Surgery IRB's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Hospital For Special Surgery IRB: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202100000
202000000
201900000
201800000
201710000

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

3 inspections from Jul 7, 2011 to Apr 30, 2025.

DateSiteProductClassificationFEI
Apr 30, 2025New York, NYDevicesNo Action Indicated (NAI)2434097
May 25, 2017New York, NYDrugsNo Action Indicated (NAI)2434097
Jul 7, 2011New York, NYDrugsVoluntary Action Indicated (VAI)2434097
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 2434097New York, NY3Apr 30, 2025

Hospital For Special Surgery IRB and the FDA: common questions

Has Hospital For Special Surgery IRB received an FDA warning letter?

No FDA warning letter addressed to the name "Hospital For Special Surgery IRB" 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 Hospital For Special Surgery IRB received an FDA Form 483?

FDA has not published a Form 483 for "Hospital For Special Surgery IRB" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hospital For Special Surgery IRB?

The most recent FDA inspection on file ended Apr 30, 2025 at New York, NY and was classified NAI. FDA has 3 inspections of Hospital For Special Surgery IRB on file.

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