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Columbus Center For Reproductive Endocrinology & Infertility, LLC FDA Record

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

Latest inspection VAI · Jul 2, 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

Columbus Center For Reproductive Endocrinology & Infertility, LLC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Columbus Center For Reproductive Endocrinology & Infertility, LLC" is on file. FDA has published 1 Form 483 for Columbus Center For Reproductive Endocrinology & Infertility, LLC.

What these totals cover: FDA records filed under the name "Columbus Center For Reproductive Endocrinology & Infertility, LLC" and its spelling variant "Columbus Center For Reproductive Endocrinology And Infertility".

Latest inspection: Jul 2, 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	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

Columbus Center For Reproductive Endocrinology & Infertility, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Columbus Center For Reproductive Endocrinology & Infertility, 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	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	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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Columbus Center For Reproductive Endocrinology & Infertility, LLC Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Jul 2, 2025 · Document on fda.gov	483	3005144073

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

7 inspections from Nov 30, 2011 to Jul 2, 2025.

Date	Site	Product	Classification	FEI
Jul 2, 2025	Columbus, GA	Biologics	Voluntary Action Indicated (VAI)	3005144073
Apr 25, 2023	Columbus, GA	Biologics	No Action Indicated (NAI)	3005144073
Jun 6, 2019	Columbus, GA	Biologics	No Action Indicated (NAI)	3005144073
May 9, 2017	Columbus, GA	Biologics	No Action Indicated (NAI)	3005144073
Sep 11, 2015	Columbus, GA	Biologics	No Action Indicated (NAI)	3005144073
Mar 11, 2014	Columbus, GA	Biologics	No Action Indicated (NAI)	3005144073
Nov 30, 2011	Columbus, GA	Biologics	No Action Indicated (NAI)	3005144073

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 3005144073	Columbus, GA	7	Jul 2, 2025

Columbus Center For Reproductive Endocrinology & Infertility, LLC and the FDA: common questions

Has Columbus Center For Reproductive Endocrinology & Infertility, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Columbus Center For Reproductive Endocrinology & Infertility, 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 Columbus Center For Reproductive Endocrinology & Infertility, LLC received an FDA Form 483?

FDA has published 1 Form 483 for Columbus Center For Reproductive Endocrinology & Infertility, LLC in its reading room, the most recent dated Jul 2, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Columbus Center For Reproductive Endocrinology & Infertility, LLC?

The most recent FDA inspection on file ended Jul 2, 2025 at Columbus, GA and was classified VAI. FDA has 7 inspections of Columbus Center For Reproductive Endocrinology & Infertility, LLC on file.

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