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Island Reproductive Services FDA Inspection Record

FEI 3011393636 · Inspections, Form 483s, warning letters and import refusals

Island Reproductive Services is an FDA-inspected facility (FEI 3011393636) located in Staten Island, NY, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 17, 2025: No Action Indicated (NAI)
Inspections on record
7 (1 VAI, 6 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 17, 2025No Action Indicated (NAI)No citations listed
Jan 26, 2023No Action Indicated (NAI)Design of procedures to ensure compliance (21 CFR 1271.47(a))
Determination based on screening and testing (21 CFR 1271.50(a))
Summary--records used to make determination (21 CFR 1271.55(a)(3))
Accurate, indelible, legible (21 CFR 1271.55(d)(2))
and 1 more
Sep 12, 2019No Action Indicated (NAI)No citations listed
Feb 16, 2017No Action Indicated (NAI)No citations listed
Apr 14, 2015Voluntary Action Indicated (VAI)Testing, screening, donor eligibility procedures (21 CFR 1271.47(a))
Accurate, indelible, legible (21 CFR 1271.55(d)(2))
May 3, 2013No Action Indicated (NAI)No citations listed
Feb 24, 2011No Action Indicated (NAI)No citations listed

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Island Reproductive Services
Location
Staten Island, NY (US)
Source
inspections

FDA data resources

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