Andrx Presents Manufacturing Corrective Action Plan To FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Andrx presented FDA with a full action plan to correct manufacturing deficiencies at a recent meeting, the company said
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FDA Accepts Andrx’ Corrective Action Plan On Manufacturing Issues
Agency’s acceptance means that manufacturing deficiencies will not result in warning letter or consent decree, and will not hold up ANDA approvals, Andrx CEO Rice says.
FDA Accepts Andrx’ Corrective Action Plan On Manufacturing Issues
Agency’s acceptance means that manufacturing deficiencies will not result in warning letter or consent decree, and will not hold up ANDA approvals, Andrx CEO Rice says.
Andrx’ Florida Manufacturing Operations Subject Of Second FDA-483 Notice
FDA has provided “conflicting information” about whether GMP issues will delay ANDA approvals, Andrx says. The company is slated to meet with FDA in the next 60 days to discuss implementation of a corrective action plan that would address Form 483 observations issued in March and July.