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AseptiKits, LLC Warning Letter Details

Warning Letter

AseptiKits, LLC

AseptiKits, LLC, 101 N. 700 W North Salt Lake , UT 84054 United States, (b)(6)

Issue DateJune 04, 2026

FEI NumberN/A

Violations2

CountryUnited States

Issuing Office

Center for Devices and Radiological Health

Product Type

Medical Devices

Status

Open

Subject

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

AseptiKits, LLC FDA Warning Letter, June 4, 2026