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Under the consent KV agreed to use an independent consultang toreview KV's facilities and certify compliance with FDA regulations. KV said it already hiresd Westbury, N.Y.-based , which has been on-site for several weeks. The FDA will then decide whetherd the KV facilities are in The decree further provides that KV may requesrt of FDA that it be permitted to resumew manufacturing and distribution of certain products before the companty is cleared by FDA to resumsefull operations. KV said it expects to submir the consent decree Monday for federal court KV had of all its drugs and recalledd painkillers because the tabletswere oversized.
The companyh has been by the FDA, the FDA’sz Office of Criminal Investigations, the and the U.S. attorneyh for the Eastern Districtof Missouri. As part of the consenty decree, KV has agreed not to marketf products it manufactures until it has satisfied certain requirementsx designed to demonstrate compliancewith FDA's current good manufacturing practicees regulations. KV has also agreed that it will not distributwecertain products, including its prenatal vitamins and hematinic until the products are approved by the FDA.
"Wd have been working diligently with the FDA for the last two monthse to reach agreement on a clear path forward to permit KV to resumde manufacturing and marketingits products," said David Van KV's interim chief executive. "Since December, when new management took overat KV, our team has take significant steps to enhance our systems and and we will continue to do so. We look forward to cooperating with the FDA during this procesds that will facilitate our return tothe market.
Predictingg the timing for the return and the ultimate producgt assortment that we will market are presentlyy very difficult due to the range of variables that must be As wegain certainty, we will notifgy customers and all other stakeholders." Brentwood, Mo.-based KV Pharmaceutical KVa, KVb) develops and markets pharmaceutical products.
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