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Billings Clinic Fertility Specialists FDA Record

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

Latest inspection NAI · Jul 22, 2025
No warning letters matched by name

Inspections 5

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Billings Clinic Fertility Specialists has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Billings Clinic Fertility Specialists" is on file. FDA has published 1 Form 483 for Billings Clinic Fertility Specialists.

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

Latest inspection: Jul 22, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Billings Clinic Fertility Specialists: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	2	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

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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Billings Clinic Fertility Specialists Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Feb 26, 2025 · Document on fda.gov	483	3028586894

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

5 inspections from Jun 18, 2015 to Jul 22, 2025.

Date	Site	Product	Classification	FEI
Jul 22, 2025	Billings, MT	Biologics	No Action Indicated (NAI)	3012341977
Feb 26, 2025	Bozeman, MT	Biologics	Voluntary Action Indicated (VAI)	3028586894
Jul 14, 2023	Billings, MT	Biologics	Voluntary Action Indicated (VAI)	3012341977
May 9, 2017	Billings, MT	Biologics	No Action Indicated (NAI)	3012341977
Jun 18, 2015	Billings, MT	Biologics	No Action Indicated (NAI)	3012341977

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.

Facility	Location	Inspections	Latest
FEI 3012341977	Billings, MT	4	Jul 22, 2025
FEI 3028586894	Bozeman, MT	1	Feb 26, 2025

Billings Clinic Fertility Specialists and the FDA: common questions

Has Billings Clinic Fertility Specialists received an FDA warning letter?

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

FDA has published 1 Form 483 for Billings Clinic Fertility Specialists in its reading room, the most recent dated Feb 26, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Billings Clinic Fertility Specialists?

The most recent FDA inspection on file ended Jul 22, 2025 at Billings, MT and was classified NAI. FDA has 5 inspections of Billings Clinic Fertility Specialists on file.

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