Aeroflex Industria de Aerosol Ltda.

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.

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 written response with FEI 3018057637 and ATTN: Bryce Hammer.