Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device: FDA Warning Letter to AseptiKits, LLC, June 4, 2026

FDA Warning Letter — Violations FDA cited at AseptiKits, LLC

WARNING LETTER AseptiKits, LLC MARCS-CMS 728184 — June 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Gale H. Thorne Jr. Recipient Title Chief Executive Officer AseptiKits, LLC 101 N. 700 W North Salt Lake , UT 84054 United States (b)(6) Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER CMS 728184 June 4, 2026 Dear Mr. Thorne: During an inspection of your firm located in North Salt Lake, UT from November 11, 2025, through December 3, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets the PALA YourTears models (8,12,14), ALAdrop, SyrilKit, and VitrALA devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Unapproved Device Violation(s) Our inspection revealed that the PALA YourTears models (8,12,14), ALAdrop, SyrilKit, and VitrALA devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have, for any of these products, an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). You stated in your response that these devices fall under product code NEP and are exempt from premarket notification under 21 CFR 880.5440(b). Under 21 CFR 880.5440(a), an intravascular administration set is a device used to administer fluids from a container to a patient’s vascular system through a needle or catheter inserted into a vein. While under 21 CFR 880.5440(b) some pharmacy compounding systems are exempt from the requirement of premarket notification, in accordance with FDA special controls guidance Pharmacy Compounding Systems - Final Class II Special Controls Guidance Document for Industry and FDA, such exemption “does not encompass the ancillary devices that make up the delivery and container system,” including “fluid transfer sets, metering chambers, I.V. bags, connectors, or other components that provide a fluid contact surface.” (This guidance document is the special control for pharmacy compounding systems within the intravascular administration set classification. 21 CFR 880.5440(b).) Such ancillary devices are classified separately from pharmacy compounding systems. FDA identifies a pharmacy compounding system as an “apparatus, often controlled by software, that is intended to deliver a specified quantity of one or more injections through a designated fluid pathway to achieve in a receiving vessel an injection having a specified concentration or proportion of ingredients different from the initial injections.” Pharmacy Compounding Systems - Final Class II Special Controls Guidance Document for Industry and FDA . Per your marketing website (www.aseptikits.com), the PALA YourTears models (8,12,14) is a closed system bag with filters and syringes intended for sterile preparation of serum. The ALAdrop is a closed system bag with syringe and filter intended for sterile eye drop preparation. The SyrilKit is a kit of 20 syringes with filters intended for sterile solution preparation. The VitrALA is a closed system bag with filters and syringes that is intended to prime and measure drug products. Therefore, the subject devices are syrin