Warning Letter — Aeroflex Industria de Aerosol Ltda.
The FDA issued a warning letter to Aeroflex Industria de Aerosol Ltda. following an evaluation by the Center for Drug Evaluation and Research (CDER) concerning Current Good Manufacturing Practice (CGMP) violations.
The warning letter directly affects Aeroflex Industria de Aerosol Ltda. and its personnel involved in the manufacturing, quality control, and regulatory compliance of aerosol drug products.
The issuance of a formal Warning Letter by CDER indicates that the facility's manufacturing processes or quality controls failed to meet statutory standards. This suggests potential risks to product quality and may lead to import alerts or restrictions on the distribution of products in the U.S. market until the cited deficiencies are remediated and verified by the agency.
Manufacturing and QA teams should ensure that all aerosol drug production facilities and processes strictly adhere to CGMP standards. Regulatory departments should verify that international manufacturing sites are prepared for CDER inspections and that documentation remains readily available for FDA review.
FDA Warning Letter issued to: Aeroflex Industria de Aerosol Ltda.. 05/22/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aeroflex-industria-de-aerosol-ltda-728186-05222026
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