AseptiKits, LLC

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.

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 syringes, filters and closed system transfer devices (bag). These devices fall under various product codes such as FMF (for syringe) and ONB (for closed system transfer devices).These product codes are for class II, non-exempt devices. The products, which contain syringes and containers for the drug, are not pharmacy compounding systems. Accordingly, the subject products are not exempt from premarket notification under 21 CFR § 880.5440(b).

In addition, we have reviewed your website, Home | Aseptikits. The website includes references to convenience kits and states “Included class II medical devices are 510(k) approved and assembled into patented convenience kits for medical use.” As noted above, however, the subject products, which are marketed on your website, have not been cleared or approved by FDA for marketing in accordance with FDA’s regulations. Nor is it true that, as your website says, “Kits meet FDA requirements for Convenient[sic] Kits.” Your website includes a statement under “Key Differentiators” that your products “Meets or exceeds FDA regulations.” Because the subject devices lack required authorization, these representations are false and misleading and a device is misbranded within the meaning of section 502(a) of the Act, 21 U.S.C. § 352(a), if its labeling is false or misleading in any particular.

For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that you immediately cease any activities that result in the misbranding or adulteration of your devices, such as the commercial distribution of your devices for the uses discussed above.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Jeff Wooley, Acting Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 728184” when replying. If you have any questions about the contents of this letter, please contact: Jeff Wooley at jeffrey.wooley@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility or associated with your firm’s devices. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.