Midwest Fertility Specialists FDA Record

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

Midwest Fertility Specialists has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Midwest Fertility Specialists" is on file. FDA has published 1 Form 483 for Midwest Fertility Specialists.

What these totals cover: FDA records filed under the name "Midwest Fertility Specialists".

Latest inspection
Nov 25, 2024 · VAI

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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
Inspections10Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Midwest Fertility Specialists: FDA inspections per year 2017: 2 inspections220172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202300000
202210000
202100000
202000000
201910000
201800000
201720000

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.

Midwest Fertility Specialists Form 483s

1 Form 483 published by FDA.

DateDocumentFEI
Nov 25, 20244833005620323

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

10 inspections from Apr 19, 2010 to Nov 25, 2024.

DateSiteProductClassificationFEI
Nov 25, 2024Carmel, INBiologicsVoluntary Action Indicated (VAI)3005620323
Mar 22, 2022Fort Wayne, INBiologicsNo Action Indicated (NAI)3005620268
Oct 16, 2019Carmel, INBiologicsNo Action Indicated (NAI)3005620323
Aug 1, 2017Fort Wayne, INBiologicsNo Action Indicated (NAI)3005620268
Jun 21, 2017Carmel, INBiologicsNo Action Indicated (NAI)3005620323
Jun 18, 2015Carmel, INBiologicsNo Action Indicated (NAI)3005620323
Mar 25, 2015Fort Wayne, INBiologicsNo Action Indicated (NAI)3005620268
Jan 31, 2013Carmel, INBiologicsVoluntary Action Indicated (VAI)3005620323
Nov 6, 2012Fort Wayne, INBiologicsNo Action Indicated (NAI)3005620268
Apr 19, 2010Carmel, INBiologicsNo Action Indicated (NAI)3005620323
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3005620323Carmel, IN6Nov 25, 2024
FEI 3005620268Fort Wayne, IN4Mar 22, 2022

Midwest Fertility Specialists and the FDA: common questions

Has Midwest Fertility Specialists received an FDA warning letter?

No FDA warning letter addressed to the name "Midwest Fertility Specialists" 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 Midwest Fertility Specialists received an FDA Form 483?

FDA has published 1 Form 483 for Midwest Fertility Specialists in its reading room, the most recent dated Nov 25, 2024. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Midwest Fertility Specialists?

The most recent FDA inspection on file ended Nov 25, 2024 at Carmel, IN and was classified VAI. FDA has 10 inspections of Midwest Fertility Specialists on file.

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