Generic drugmaker KVK Research pleaded guilty last week to charges that it "introduced adulterated drugs into interstate commerce" in violation of the Federal Food, Drug and Cosmetic Act, agreeing to pay $1.5 million in fines and forfeiture, DOJ announced.
The European Council and Parliament reached a deal on a new set of rules to ban imports suspected of being made with forced labor, including how the ban will be enforced and how the bloc will investigate and penalize violations.
Because the FDA is not able to inspect foreign pharmaceutical factories with enough frequency -- and because the quality of those inspections is compromised by several factors -- some suggest that more imported drugs should be inspected at the border to ensure quality.
The U.S. District Court for the Southern District of New York on Jan. 26 declined to dismiss a False Claims Act suit from a whistleblower that alleges her employer misclassified footwear to avoid tariffs. Magistrate Judge Robert Lehrburger said the fact none of the defendants served as the importer of record for the allegedly undervalued footwear imports is irrelevant for purposes of establishing liability under the FCA (United States ex rel. Devin Taylor v. GMI USA Corp., S.D.N.Y. # 16-7216).