FDA Warning Letter to Aeroflex Industria de Aerosol Ltda. (2026-05-22) — Refusal to Provide Access to and Copying of Records
Letter issued · posted to fda.gov .
Subject as published: Refusal to Provide Access to and Copying of Records
TL;DR
In short: FDA issued a Warning Letter to Aeroflex Industria de Aerosol Ltda. on 2026-05-22 citing: Refusal to Provide Access to and Copying of Records. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aeroflex-industria-de-aerosol-ltda-728186-05222026
Argus analysis
Aeroflex Industria de Aerosol Ltda. (MARCS-CMS 728186, FEI 3018057637) received an FDA Warning Letter dated May 22, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: Refusal to Provide Access to and Copying of Records. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on June 2, 2026.
Letters citing refusal of inspection access reference section 704 of the FD&C Act, which grants FDA the statutory right to inspect and copy records. A documented refusal is treated as a standalone violation and, per section 801(a), can independently support refusing admission of the firm's products into the United States.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same general compliance category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
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
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 Aeroflex Industria de Aerosol Ltda. MARCS-CMS 728186 — May 22, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-79 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Márcio Paranhos Miksza Recipient Title CEO Aeroflex Industria de Aerosol Ltda. Rua Paul Garfunkel, 1335 Cidade Industrial de Curitiba Curitiba - PR 81460-040 Brazil Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-79 May 22, 2026 Dear Mr. Miksza: Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter drug products. Previous correspondence you sent to the FDA indicated manufacture and importation of multiple drug products. Additionally, your (b)(4) drug product is available for purchase via online marketplaces. On October 27, 2025, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered as did numerous follow-up requests. It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a). Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs listed as manufactured at your facility. Conclusion Respond to this letter to confirm or update your registration and/or drug listing status and indicate whether you will respond to the request for records and other information. If you are no longer manufacturing drugs, delist all the drugs previously listed with FDA, using the last lot expiration date as the marketing end date of the product, and deregister your facility accordingly. Until FDA is able to confirm compliance with current good manufacturing practices and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Aeroflex Industria de Aerosol Ltda., at Rua Paul Garfunkel, 1335, Cidade Industrial de Curitiba, Curitiba – Paraná CEP 81460-040 into the United States that appear to be adulterated are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection. Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your wr…
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 "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 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 Aeroflex Industria de Aerosol Ltda. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Aeroflex Industria de Aerosol Ltda. as of 2026-06-02. 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 Aeroflex Industria de Aerosol Ltda. (2026-05-22) — Refusal to Provide Access to and Copying of Records. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-aeroflex-industria-de-aerosol-ltda-2026-05-22-warning-letter
"FDA Warning Letter to Aeroflex Industria de Aerosol Ltda. (2026-05-22) — Refusal to Provide Access to and Copying of Records." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-aeroflex-industria-de-aerosol-ltda-2026-05-22-warning-letter.
Argus HQ Research. "FDA Warning Letter to Aeroflex Industria de Aerosol Ltda. (2026-05-22) — Refusal to Provide Access to and Copying of Records." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-aeroflex-industria-de-aerosol-ltda-2026-05-22-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_aeroflex_industria_de_aerosol_ltda_2026_05_22_warning_letter_2026,
title = {FDA Warning Letter to Aeroflex Industria de Aerosol Ltda. (2026-05-22) — Refusal to Provide Access to and Copying of Records},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-aeroflex-industria-de-aerosol-ltda-2026-05-22-warning-letter},
note = {Accessed: July 13, 2026}
}