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Boston IVF Fertility Services At The Women's Hospital, LLC FDA Record

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

Latest inspection VAI · Sep 9, 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

Boston IVF Fertility Services At The Women's Hospital, LLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Boston IVF Fertility Services At The Women's Hospital, LLC" is on file. FDA has published 1 Form 483 for Boston IVF Fertility Services At The Women's Hospital, LLC.

What these totals cover: FDA records filed under the name "Boston IVF Fertility Services At The Women's Hospital, LLC" and its spelling variant "Boston Ivf Fertility Services At The Women Hospital". Records filed under related names are not included; see Related names.

Latest inspection: Sep 9, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 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

Boston IVF Fertility Services At The Women's Hospital, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Boston IVF Fertility Services At The Women's Hospital, LLC: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	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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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Boston IVF Fertility Services At The Women's Hospital, LLC above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Boston Ivf Combines 2 spellings Boston Ivf: 6 inspections Boston Ivf, Inc: 5 inspections	Same company group	0	0	11	0	—

Boston IVF Fertility Services At The Women's Hospital, LLC Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Sep 9, 2025 · Document on fda.gov	483	3010149285

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 May 6, 2013 to Sep 9, 2025.

Date	Site	Product	Classification	FEI
Sep 9, 2025	Newburgh, IN	Biologics	Voluntary Action Indicated (VAI)	3010149285
Apr 5, 2022	Newburgh, IN	Biologics	No Action Indicated (NAI)	3010149285
Aug 9, 2017	Newburgh, IN	Biologics	No Action Indicated (NAI)	3010149285
Jul 14, 2015	Newburgh, IN	Biologics	No Action Indicated (NAI)	3010149285
May 6, 2013	Newburgh, IN	Biologics	No Action Indicated (NAI)	3010149285

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.

Facility	Location	Inspections	Latest
FEI 3010149285	Newburgh, IN	5	Sep 9, 2025

Boston IVF Fertility Services At The Women's Hospital, LLC and the FDA: common questions

Has Boston IVF Fertility Services At The Women's Hospital, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Boston IVF Fertility Services At The Women's Hospital, 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 Boston IVF Fertility Services At The Women's Hospital, LLC received an FDA Form 483?

FDA has published 1 Form 483 for Boston IVF Fertility Services At The Women's Hospital, LLC in its reading room, the most recent dated Sep 9, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Boston IVF Fertility Services At The Women's Hospital, LLC?

The most recent FDA inspection on file ended Sep 9, 2025 at Newburgh, IN and was classified VAI. FDA has 5 inspections of Boston IVF Fertility Services At The Women's Hospital, LLC on file.

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