Issued to Aeroflex Industria de Aerosol Ltda.. Serious post-market compliance violation.
Issued
May 22, 2026Product
Refusal to Provide Access to and Copying of Records
Company
Aeroflex Industria de Aerosol Ltda.
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Aeroflex Industria de Aerosol Ltda. concerning Refusal to Provide Access to and Copying of Records. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on May 22, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.