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Fertility Center Of The Carolinas FDA Record

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

Latest inspection NAI · Mar 11, 2025
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Fertility Center Of The Carolinas has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Fertility Center Of The Carolinas" is on file.

What these totals cover: FDA records filed under the name "Fertility Center Of The Carolinas".

Latest inspection: Mar 11, 2025 · NAI

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	7	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

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

Fertility Center Of The Carolinas: 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	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

7 inspections from Jan 25, 2012 to Mar 11, 2025.

Date	Site	Product	Classification	FEI
Mar 11, 2025	Greenville, SC	Biologics	No Action Indicated (NAI)	3003935952
Dec 5, 2022	Greenville, SC	Biologics	No Action Indicated (NAI)	3003935952
Jan 30, 2020	Greenville, SC	Biologics	No Action Indicated (NAI)	3003935952
Apr 18, 2018	Greenville, SC	Biologics	No Action Indicated (NAI)	3003935952
Apr 20, 2016	Greenville, SC	Biologics	No Action Indicated (NAI)	3003935952
Apr 30, 2014	Greenville, SC	Biologics	No Action Indicated (NAI)	3003935952
Jan 25, 2012	Greenville, SC	Biologics	No Action Indicated (NAI)	3003935952

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 3003935952	Greenville, SC	7	Mar 11, 2025

Fertility Center Of The Carolinas and the FDA: common questions

Has Fertility Center Of The Carolinas received an FDA warning letter?

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

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

When did the FDA last inspect Fertility Center Of The Carolinas?

The most recent FDA inspection on file ended Mar 11, 2025 at Greenville, SC and was classified NAI. FDA has 7 inspections of Fertility Center Of The Carolinas on file.

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