Suretec Innovations, LLC — FDA Warning Letter, 2026-08-13: CGMP/Finished Pharmaceuticals/Adulterated and Misbranded
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated and Misbranded
TL;DR
FDA Center for Drug Evaluation and Research issued Warning Letter 320-26-114 on August 13, 2026, to Suretec Innovations, LLC (FEI 3030456591, Gilbert, Arizona) following a March 2-5, 2026 inspection. The letter cites CGMP violations under 21 CFR parts 210 and 211, including failure to test component identity and conformity to specifications, failure to validate supplier test reliability, and failure to list KleenLine Alcohol-Free Sanitizing Wipes in the FDA's eDRLS system, rendering the products adulterated and misbranded.
Argus analysis
# FDA Warning Letter Analysis: Suretec Innovations, LLC
**Company and Violations**
Suretec Innovations, LLC, a finished pharmaceutical manufacturer in Gilbert, Arizona, received a warning letter from the FDA's Center for Drug Evaluation and Research (CDER) on August 13, 2026, following an inspection conducted March 2–5, 2026. The FDA identified significant violations of Current Good Manufacturing Practice (CGMP) regulations in the manufacture of over-the-counter drugs, rendering products adulterated. Additionally, the firm failed to register KleenLine Alcohol-Free Sanitizing Wipes in the FDA's drug listing system, making that product misbranded. The warning letter was addressed to President Travis Brady.
**Regulatory Citations and Their Meaning**
The violations center on three core CGMP requirements under 21 CFR parts 210 and 211. First, 21 CFR 211.84(d) requires firms to test incoming components for identity and purity and validate supplier test results periodically—Suretec conducted inadequate identity testing of active pharmaceutical ingredients and relied uncritically on supplier certificates of analysis. Second, 21 CFR 211.165(b) mandates microbiological testing of each batch; Suretec's non-compendial testing lacked proper incubation times, controls, and validation. Third, 21 CFR 211.192 requires thorough investigation of out-of-specification results; Suretec distributed products manufactured from components with microbial counts exceeding limits without adequate investigation. The firm also violated 21 CFR 510(j) by failing to list KleenLine Wipes, triggering misbranding under the FD&C Act.
**Response Timeline and Industry Monitoring**
The firm submitted a response on March 25, 2026, which the FDA deemed inadequate. Compliance officers in contract manufacturing and OTC drug production should monitor whether Suretec issues a comprehensive corrective action plan addressing component supplier qualification, retrospective testing of retained samples, and deviation investigation procedures. The FDA explicitly requested documentation of microbiological testing results, supplier validation protocols, and timelines for testing distributed batches still within expiry. Watchpoints include product recalls, customer notifications, and potential import alerts if corrective actions remain insufficient.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
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 Suretec Innovations, LLC MARCS-CMS 730122 — August 13, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-114 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Travis Brady Recipient Title President Suretec Innovations, LLC 7055 South Lindell Road Las Vegas , NV 89118 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-114 August 13, 2026 Dear Mr. Brady: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Suretec Innovations, LLC, FEI 3030456591, at 190 South McQueen Road, Suite 102, Gilbert, Arizona, from March 2 to 5, 2026. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). In addition, violations were identified and documented during a review of your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS). Based on our review, you failed to provide drug listing information for KleenLine Alcohol-Free Sanitizing Wipes, a drug you are manufacturing on behalf of a private label distributor (PLD). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act, 21 U.S.C. 360(j), is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Therefore, this drug is misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introducing or delivering for introduction into interstate commerce, or the causing thereof, of this drug is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below. We reviewed your March 25, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigator observed specific violations including, but not limited to, the following. CGMP Violations 1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm contract manufactures over-the-counter (OTC) (b)(4) containing the active pharmaceutical ingredient (API) (b)(4) . You failed to conduct adequate identity testing of incoming components, including the API, used in the manufacturing …
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
- When did FDA issue the warning letter to Suretec Innovations, LLC?
- FDA issued the letter (MARCS-CMS 730122) on 2026-08-13 and posted it publicly on fda.gov on 2026-08-18.
- Is the FDA warning letter to Suretec Innovations, LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/suretec-innovations-llc-730122-08132026.
- What does a "high" severity rating mean for this letter?
- High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
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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). Suretec Innovations, LLC — FDA Warning Letter, 2026-08-13: CGMP/Finished Pharmaceuticals/Adulterated and Misbranded. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-suretec-innovations-llc-2026-08-13-cgmp
"Suretec Innovations, LLC — FDA Warning Letter, 2026-08-13: CGMP/Finished Pharmaceuticals/Adulterated and Misbranded." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-suretec-innovations-llc-2026-08-13-cgmp.
Argus HQ Research. "Suretec Innovations, LLC — FDA Warning Letter, 2026-08-13: CGMP/Finished Pharmaceuticals/Adulterated and Misbranded." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/fda/warning-letter/fda-wl-suretec-innovations-llc-2026-08-13-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_suretec_innovations_llc_2026_08_13_cgmp_2026,
title = {Suretec Innovations, LLC — FDA Warning Letter, 2026-08-13: CGMP/Finished Pharmaceuticals/Adulterated and Misbranded},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-suretec-innovations-llc-2026-08-13-cgmp},
note = {Accessed: August 19, 2026}
}