FDA Warning Letter to AseptiKits, LLC (2026-06-04) — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Letter issued · posted to fda.gov .
Subject as published: Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
TL;DR
The short version: On June 4, 2026, the FDA's Center for Devices and Radiological Health issued a warning letter to AseptiKits, LLC (CMS 728184) stating that the PALA YourTears models (8, 12, 14), ALAdrop, SyrilKit, and VitrALA devices are adulterated and misbranded because they lack required premarket approval (PMA) or investigational device exemption (IDE) authorization and were not subject to the 510(k) exemption AseptiKits claimed. The FDA determined these products—composed of syringes, filters, and closed-system transfer bags—are classified as Class II devices under product codes FMF and ONB, not exempt pharmacy compounding systems, and that AseptiKits's website claims about FDA approval and regulatory compliance are false and misleading.
Argus analysis
# FDA Warning Letter: AseptiKits, LLC — Unapproved Medical Devices
AseptiKits, LLC, based in North Salt Lake, Utah, manufactures and distributes five medical device products: PALA YourTears models (8, 12, 14), ALAdrop, SyrilKit, and VitrALA. An FDA inspection conducted November–December 2025 found these devices to be adulterated and misbranded under federal law. The Center for Devices and Radiological Health (CDRH) issued the warning letter on June 4, 2026, citing the company's failure to obtain required premarket approval or clearance before commercial distribution.
The violations center on three regulatory pathways. Under 21 U.S.C. § 321(h) and 21 CFR 501(f)(1)(B), devices intended for diagnosis or treatment require either an approved Premarket Approval (PMA) application or an active Investigational Device Exemption (IDE)—neither of which AseptiKits held. Additionally, 21 U.S.C. § 360(k) requires a 510(k) premarket notification for Class II devices. The company incorrectly claimed exemption under 21 CFR 880.5440(b), which covers only pharmacy compounding systems, not the syringes, filters, and closed-system transfer bags that comprise these kits. The devices also violated 21 U.S.C. § 352(a) due to false website claims stating products were "510(k) approved" and "meet FDA regulations"—representations contradicted by their unauthorized status.
AseptiKits has 15 business days from receipt to respond to CDRH at CDRHEnforcement@fda.hhs.gov (case CMS 728184), detailing corrective actions and timelines. The response must address systemic quality issues, not merely product-level fixes. Peers in sterile preparation device manufacturing should note that misclassification of product codes and reliance on outdated exemptions remain high-risk compliance failures. The FDA cautioned that failure to remedy violations may trigger seizure, injunction, or civil penalties, and may affect federal contract eligibility.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
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 co…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has AseptiKits, LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for AseptiKits, LLC as of 2026-06-30. Argus ingests new FDA enforcement records daily.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Warning Letter to AseptiKits, LLC (2026-06-04) — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-aseptikits-llc-2026-06-04-warning-letter
"FDA Warning Letter to AseptiKits, LLC (2026-06-04) — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-aseptikits-llc-2026-06-04-warning-letter.
Argus HQ Research. "FDA Warning Letter to AseptiKits, LLC (2026-06-04) — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-aseptikits-llc-2026-06-04-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_aseptikits_llc_2026_06_04_warning_letter_2026,
title = {FDA Warning Letter to AseptiKits, LLC (2026-06-04) — Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-aseptikits-llc-2026-06-04-warning-letter},
note = {Accessed: July 13, 2026}
}