Global Premier Fertility Orange County LLC FDA Record

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

Global Premier Fertility Orange County LLC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Global Premier Fertility Orange County LLC" is on file. FDA has published 1 Form 483 for Global Premier Fertility Orange County LLC.

What these totals cover: FDA records filed under the name "Global Premier Fertility Orange County LLC" and its spelling variant "Global Premier Fertility Orange County".

Latest inspection
Apr 11, 2025 · 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
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Global Premier Fertility Orange County LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Global Premier Fertility Orange County LLC: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202110000
202000000
201900000
201800000
201700000

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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Global Premier Fertility Orange County LLC Form 483s

1 Form 483 published by FDA.

DateDocumentFEI
Apr 11, 20254833018118424

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

2 inspections from Oct 8, 2021 to Apr 11, 2025.

DateSiteProductClassificationFEI
Apr 11, 2025Newport Beach, CABiologicsVoluntary Action Indicated (VAI)3018118424
Oct 8, 2021Newport Beach, CABiologicsNo Action Indicated (NAI)3018118424
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 3018118424Newport Beach, CA2Apr 11, 2025

Global Premier Fertility Orange County LLC and the FDA: common questions

Has Global Premier Fertility Orange County LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Global Premier Fertility Orange County LLC" 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 Global Premier Fertility Orange County LLC received an FDA Form 483?

FDA has published 1 Form 483 for Global Premier Fertility Orange County LLC in its reading room, the most recent dated Apr 11, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Global Premier Fertility Orange County LLC?

The most recent FDA inspection on file ended Apr 11, 2025 at Newport Beach, CA and was classified VAI. FDA has 2 inspections of Global Premier Fertility Orange County LLC on file.

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