This article was originally published in The Tan Sheet
Generics firm met with FDA to discuss "inspectional observations" detailed in two Form 483s issued by the agency earlier this year, Andrx announces Sept. 8. The firm detailed corrective measures implemented at its Florida manufacturing facilities, and believes FDA "will be satisfied with the company's corrective action plan, that no regulatory action will be taken" and that the firm will continue to have its ANDAs approved "in due course." CEO Thomas Rice says Andrx is "committed to quality throughout its organization"...
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