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Blue Sky Fertility Services LLC

FDA Regulatory Profile

Blue Sky Fertility Services LLC has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Blue Sky Fertility Services LLC" and its spelling variant "Blue Sky Fertility Services".

Latest inspection
Apr 18, 2025 · NAI

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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
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Blue Sky Fertility Services LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Blue Sky Fertility Services LLC: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202310000
202200000
202100000
202000000
201900000
201810000
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.

Recent FDA inspections

3 inspections from Jun 28, 2018 to Apr 18, 2025.

DateSiteProductClassificationFEI
Apr 18, 2025Overland Park, KSBiologicsNo Action Indicated (NAI)3013167853
Sep 6, 2023Overland Park, KSBiologicsNo Action Indicated (NAI)3013167853
Jun 28, 2018Overland Park, KSBiologicsVoluntary Action Indicated (VAI)3013167853
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 3013167853Overland Park, KS3Apr 18, 2025

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FDA data resources

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