FDA enters into consent decree; Agrees to timely complete triclosan OTC drug antiseptic monographs By Kurt R. Karst – After more than three years of litigation that started with a July 2010 ...

As part of the consent decree, KV has agreed not to market products it manufactures until it has satisfied certain requirements designed to demonstrate compliance with FDA's current good ...

The Justice Department, working with the Food and Drug Administration, filed the consent decree along with a legal complaint alleging that Medtronic and two executives—Chairman and Chief ...

CPAP maker Phillips enters consent decree that stops company from selling machines The FDA’s website says that ingesting the sound-dampening foam comes with the risks of headache, asthma ...

Abbott agrees to consent decree with FDA, could restart plant within 2 weeks, pending court approval. By CNN. May 17, 2022. Share. Powder milk for baby and blue spoon on light background close-up.

The baby formula manufacturer at the heart of a nationwide formula recall said Monday that it has reached an agreement with the US Food and Drug Administration to enter into a consent decree, a ...

Company prohibited from distributing drug products that violate the law SILVER SPRING, Md., Dec. 19, 2022 /PRNewswire/ -- Today, the U.S. District Court for the Western District of Oklahoma ...

Philips started discussions with the DOJ in July 2022 over the terms of a proposed consent decree. On Jan 29, 2024, the company agreed on the terms of the consent decree ahead of the final agreement.

To prepare to carry out the terms of the consent decree, Philips took a provision of 363 million euros in the fourth quarter of 2023, which it said will cover “remediation activities, inventory ...

FDA Announces Federal Court Enters Consent Decree Against Florida-based Drug Importer and Distributor. PRESS RELEASE PR Newswire . Jan. 30, 2023, 04:37 PM.

Drawing the largest penalty ever levied by the U.S. Food and Drug Administration, Schering-Plough Corp. agreed to pay $500 million as part of a consent decree to resolve manufacturing problems at ...

Company to focus on design changes for medical device. Officials with Minneapolis-based Medtronic Inc. said the company has reached an agreement on the terms of a consent decree with the U.S. Food ...