FDA WARNING_LETTER - 23andMe, Inc. - Unknown Date

FDA WARNING_LETTER for 23andMe, Inc. on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for 23andMe, Inc. on Unknown Date. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

FD&C Act 520(g)

FD&C Act 502(o)

FD&C Act 510(k)

21 U.S.C. 360c(f)

21 U.S.C. 351(f)(1)(B)

FD&C Act 201(h)

21 CFR 807.87(1)

21 U.S.C. 321(h)

FD&C Act 515(a)

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Record Information

Company

23andMe, Inc.

Inspection Date

Unknown Date

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Alberto Gutierrez (Director)

ID: 11c43ce0-ec96-4898-9844-f0950b820057

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