Home » FDA Warns IriSys Over GMPs, Making Unapproved Drug
FDA Warns IriSys Over GMPs, Making Unapproved Drug
The FDA has warned IriSys for GMP violations and for manufacturing an unapproved new drug. IriSys received an Aug. 23 warning letter for manufacturing violations observed during a March 16 to April 1 inspection. The San Diego company lacked adequate change control for equipment and process modifications made during the process qualification stage of the process validation for Donnatal Elixir. IriSys’ three Form 483 responses lacked sufficient corrective actions, the letter says.
Drug GMP Report
Drug GMP Report
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