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Lin, James P MD Inc. D.B.A. Reproductive Fertility Center FDA Inspection Record

FEI 3005405736 · Inspections, Form 483s, warning letters and import refusals

Lin, James P MD Inc. D.B.A. Reproductive Fertility Center is an FDA-inspected facility (FEI 3005405736) located in Irvine, CA, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 12, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (3 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
Form 483 and inspection documents
1 in FDA's reading room

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
Mar 12, 2025Voluntary Action Indicated (VAI)Determination based on screening and testing (21 CFR 1271.50(a))
Reasons for ineligibility on summary (21 CFR 1271.55(b)(4))
Labeled re: biohazard, risks, test results (21 CFR 1271.65(b)(2))
Specimen collections not timely (21 CFR 1271.80(b))
and 2 more
Oct 19, 2022No Action Indicated (NAI)No citations listed
Oct 30, 2017No Action Indicated (NAI)No citations listed
Dec 24, 2013Voluntary Action Indicated (VAI)Testing, screening, donor eligibility procedures (21 CFR 1271.47(a))
Donor testing not negative for CD agents (21 CFR 1271.50(b)(2))
Listing and interpretation of CD tests performed (21 CFR 1271.55(b)(2))
Documentation maintained (general) (21 CFR 1271.55(d)(1))
and 3 more
Jan 11, 2013No Action Indicated (NAI)No citations listed
Feb 28, 2011No Action Indicated (NAI)No citations listed
Jan 15, 2009Voluntary Action Indicated (VAI)Procedures for all other requirements (21 CFR 1271.47(a))
Review and approval of procedures (21 CFR 1271.47(b))
Determination based on screening and testing (21 CFR 1271.50(a))
Responsible person to determine, document (21 CFR 1271.50(a))
and 7 more

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Mar 12, 2025, which is not always the inspection or issue date. Published by FDA Oct 30, 2026.

FDA record score

6 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 14, 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.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 12, 20256 x 16
Inspection classified VAIDec 24, 201310 years or older, so it adds no points0
Inspection classified VAIJan 15, 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 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
Lin, James P MD Inc. D.B.A. Reproductive Fertility Center
Location
Irvine, CA (US)
Source
inspections

FDA data resources

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