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Carolinas Fertility Institute FDA Record

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

Latest inspection NAI · May 2, 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

Carolinas Fertility Institute has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Carolinas Fertility Institute" is on file.

What these totals cover: FDA records filed under the name "Carolinas Fertility Institute".

Latest inspection: May 2, 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

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

Carolinas Fertility Institute: 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	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	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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Recent FDA inspections

5 inspections from May 19, 2016 to May 2, 2025.

Date	Site	Product	Classification	FEI
May 2, 2025	Winston Salem, NC	Biologics	No Action Indicated (NAI)	3011497718
Jul 27, 2023	Winston Salem, NC	Biologics	No Action Indicated (NAI)	3011497718
Feb 26, 2020	Winston Salem, NC	Biologics	No Action Indicated (NAI)	3011497718
Feb 14, 2018	Winston Salem, NC	Biologics	No Action Indicated (NAI)	3011497718
May 19, 2016	Winston Salem, NC	Biologics	Voluntary Action Indicated (VAI)	3011497718

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 3011497718	Winston Salem, NC	5	May 2, 2025

Carolinas Fertility Institute and the FDA: common questions

Has Carolinas Fertility Institute received an FDA warning letter?

No FDA warning letter addressed to the name "Carolinas Fertility Institute" 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 Carolinas Fertility Institute received an FDA Form 483?

FDA has not published a Form 483 for "Carolinas Fertility Institute" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Carolinas Fertility Institute?

The most recent FDA inspection on file ended May 2, 2025 at Winston Salem, NC and was classified NAI. FDA has 5 inspections of Carolinas Fertility Institute on file.

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