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# FDA Warns Brazilian Drug Maker Over Records Request
- URL: https://www.fdaweb.com/fda-warns-brazilian-drug-maker-over-records-request/
- Published: 2026-06-03T12:00:00.000Z
- Updated: 2026-09-14T13:40:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161248

FDA has issued a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed to respond to multiple agency requests for manufacturing records related to drug products sold in the U.S.

In a just-posted 5/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aeroflex-industria-de-aerosol-ltda-728186-05222026?ref=fdaweb.com), FDA said Aeroflex did not respond to a 10/2025 request for records and information issued under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. The agency said follow-up communications also went unanswered.

According to the agency, previous correspondence from the company indicated that it manufactures and imports multiple drug products, and at least one of its products is available for purchase through online marketplaces in the U.S.

It further said Aeroflex's failure to provide the requested records constitutes a prohibited act under federal law because FDA investigators are entitled to access records necessary to evaluate compliance with drug manufacturing requirements.

The letter directs Aeroflex to confirm or update its facility registration and drug listing status and indicate whether it will comply with the agency's records request. FDA also instructed the company to delist any products no longer being manufactured and deregister the facility if it has ceased drug production.

The agency warned that until it can verify compliance with current good manufacturing practice requirements and other applicable regulations, it may withhold approval of any new drug applications or supplements that identify Aeroflex as a manufacturer. It also said products made at the facility could be detained or refused entry at the U.S. border if they appear to be adulterated under the Federal Food, Drug, and Cosmetic Act.