The Stamford Hospital FDA Record

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

  • Latest inspection VAI · Mar 2, 2026
  • No warning letters matched by name
Inspections 8 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

The Stamford Hospital has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "The Stamford Hospital" is on file.

What these totals cover: FDA records filed under the name "The Stamford Hospital" and its spelling variant "Stamford Hospital".

Latest inspection
Mar 2, 2026 · VAI

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
Inspections8Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

The Stamford Hospital: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202500000
202400000
202310000
202200000
202100000
202000000
201910000
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

8 inspections from Dec 15, 2010 to Mar 2, 2026.

DateSiteProductClassificationFEI
Mar 2, 2026Stamford, CTBiologicsVoluntary Action Indicated (VAI)1273427
May 2, 2023Stamford, CTBiologicsNo Action Indicated (NAI)1273427
Dec 6, 2019Stamford, CTBiologicsNo Action Indicated (NAI)1273427
Nov 30, 2017Stamford, CTBiologicsNo Action Indicated (NAI)1273427
Dec 17, 2015Stamford, CTBiologicsNo Action Indicated (NAI)1273427
Nov 21, 2013Stamford, CTBiologicsNo Action Indicated (NAI)1273427
Jul 17, 2012Stamford, CTBiologicsNo Action Indicated (NAI)1273427
Dec 15, 2010Stamford, CTBiologicsVoluntary Action Indicated (VAI)1273427
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 1273427Stamford, CT8Mar 2, 2026

The Stamford Hospital and the FDA: common questions

Has The Stamford Hospital received an FDA warning letter?

No FDA warning letter addressed to the name "The Stamford Hospital" 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 The Stamford Hospital received an FDA Form 483?

FDA has not published a Form 483 for "The Stamford Hospital" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect The Stamford Hospital?

The most recent FDA inspection on file ended Mar 2, 2026 at Stamford, CT and was classified VAI. FDA has 8 inspections of The Stamford Hospital on file.

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