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Aeroflex Industria de Aerosol Ltda. Warning Letter Details
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Aeroflex Industria de Aerosol Ltda.
Recipient Name Mr. Márcio Paranhos Miksza, Rua Paul Garfunkel, 1335 Cidade Industrial de Curitiba Curitiba - PR 81460-040 Brazil
Issue Date
May 22, 2026
FEI Number
3018057637
Violations
1
Country
Brazil
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Subject
Refusal to Provide Access to and Copying of Records
Aeroflex Industria de Aerosol Ltda. FDA Warning Letter, May 22, 2026