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23andMe Genomics LLC FDA Record

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

23andMe Genomics LLC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to 23andMe Genomics LLC, the most recent on Nov 22, 2013.

What these totals cover: FDA records filed under the name "23andMe Genomics LLC" and its spelling variant "23Andme Genomics".

Latest inspection: Aug 21, 2026 · 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	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

23andMe Genomics LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	1	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	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	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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23andMe Genomics LLC FDA Warning Letters

1 warning letter on Nov 22, 2013.

Issued	Subject	Issuing office	Close-out letter
Nov 22, 2013

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Jun 13, 2019 to Aug 21, 2026.

Date	Site	Product	Classification	FEI
Aug 21, 2026	Palo Alto, CA	Devices	No Action Indicated (NAI)	3007699459
Jun 13, 2019	Palo Alto, CA	Devices	No Action Indicated (NAI)	3007699459

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under 23andMe Genomics LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 22, 2013.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3007699459	Palo Alto, CA	2	Aug 21, 2026

23andMe Genomics LLC and the FDA: common questions

Has 23andMe Genomics LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to 23andMe Genomics LLC. The most recent is dated Nov 22, 2013.

Has 23andMe Genomics LLC received an FDA Form 483?

FDA has not published a Form 483 for "23andMe Genomics LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect 23andMe Genomics LLC?

The most recent FDA inspection on file ended Aug 21, 2026 at Palo Alto, CA and was classified NAI. FDA has 2 inspections of 23andMe Genomics LLC on file.

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