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All Warning Letters

AseptiKits, LLC

Warning LetterOpen

AseptiKits, LLC, 101 N. 700 W North Salt Lake , UT 84054 United States, (b)(6)Issued Jun 4, 2026Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateJun 4, 2026

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: AseptiKits, LLC
Location: AseptiKits, LLC, 101 N. 700 W North Salt Lake , UT 84054 United States, (b)(6)
FEI Number: N/A
Country: United States
Issue Date: June 04, 2026
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