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Arizona Center For Reproductive Endocrinology & Infertility FDA Inspection Record

FEI 3005391124 · Inspections, Form 483s, warning letters and import refusals

Arizona Center For Reproductive Endocrinology & Infertility is an FDA-inspected facility (FEI 3005391124) located in Tucson, AZ, US. RegDataLab tracks 9 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jun 12, 2024: No Action Indicated (NAI)
Inspections on record
9 (5 VAI, 4 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
Jun 12, 2024No Action Indicated (NAI)No citations listed
Jun 28, 2023Voluntary Action Indicated (VAI)Testing, screening, donor eligibility procedures (21 CFR 1271.47(a))
Summary--records used to make determination (21 CFR 1271.55(a)(3))
Listing and interpretation of CD tests performed (21 CFR 1271.55(b)(2))
Name and personal info on accompanying records (21 CFR 1271.55(c))
and 3 more
Jun 22, 2022No Action Indicated (NAI)Determination based on screening and testing (21 CFR 1271.50(a))
Donor screening standards (21 CFR 1271.50(b)(1))
Listing and interpretation of CD tests performed (21 CFR 1271.55(b)(2))
Completion of eligibility determination (21 CFR 1271.60(a))
and 3 more
Aug 26, 2021Voluntary Action Indicated (VAI)No citations listed
Mar 22, 2017No Action Indicated (NAI)No citations listed
Sep 16, 2015No Action Indicated (NAI)No citations listed
Nov 3, 2011Voluntary Action Indicated (VAI)No citations listed
Sep 22, 2010Voluntary Action Indicated (VAI)Testing, screening, donor eligibility procedures (21 CFR 1271.47(a))
Responsible person to determine, document (21 CFR 1271.50(a))
Sep 30, 2009Voluntary Action Indicated (VAI)Procedures for all other requirements (21 CFR 1271.47(a))
Responsible person to determine, document (21 CFR 1271.50(a))
Summary--records used to make determination (21 CFR 1271.55(a)(3))
Risk factors, clinical evidence (21 CFR 1271.75(a)(1))
and 1 more

FDA record score

5 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

5 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIJun 28, 20236 x 0.63.6
Inspection classified VAIAug 26, 20216 x 0.251.5
Inspection classified VAINov 3, 201110 years or older, so it adds no points0
Inspection classified VAISep 22, 201010 years or older, so it adds no points0
Inspection classified VAISep 30, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Arizona Center For Reproductive Endocrinology & Infertility
Location
Tucson, AZ (US)
Source
inspections

FDA data resources

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