FDA WARNING_LETTER - ASEPTIKITS, LLC - December 03, 2025

The FDA issued a Warning Letter to AseptiKits, LLC, following an inspection of its North Salt Lake, Utah facility conducted from November 11 to December 3, 2025. The regulatory review determined that several of the company’s products, including the PALA YourTears models, ALAdrop, SyrilKit, and VitrALA, are being marketed in violation of the Federal Food, Drug, and Cosmetic Act. The primary issue is that these products are classified as medical devices but lack the necessary FDA premarket approval or clearance, rendering them adulterated and misbranded. Although the company argued these devices were exempt from certain notification requirements as pharmacy compounding systems, the FDA concluded that they are actually ancillary components—such as syringes, filters, and transfer bags—that require formal regulatory submission. Furthermore, the agency identified false and misleading claims on the company’s website, which incorrectly stated that the kits were "FDA approved" and met all regulatory requirements. AseptiKits is required to immediately stop the commercial distribution of these unauthorized devices and must provide a written response to the FDA within 15 business days. This response must detail the corrective actions taken and the company’s plan to prevent future violations. Failure to comply may result in additional enforcement actions, including product seizures, injunctions, or civil financial penalties.