FDA WARNING_LETTER - Aeroflex Industria de Aerosol Ltda - October 27, 2025

On May 22, 2026, the FDA issued a warning letter to Aeroflex Industria de Aerosol Ltda., a Brazil-based manufacturer of over-the-counter (OTC) drug products. The enforcement action stems from the company"s failure to respond to a formal request for records and information initiated on October 27, 2025, under section 704(a)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act. Despite multiple follow-up attempts, the firm failed to provide the necessary documentation, preventing the FDA from verifying the quality assurance and safety of the drugs produced at the facility. According to the regulatory framework, refusing to grant access to requested records is a prohibited act under section 301(e) of the FD&C Act. Consequently, the FDA may withhold approval for new drug applications associated with the firm and has warned that Aeroflex products are subject to detention or refusal of admission into the United States under section 801(a)(3). The FDA requires Aeroflex to respond within 15 working days to update its registration status, provide the requested records, or formally deregister and delist its products if it has ceased manufacturing for the U.S. market.