More than 30 generic drugs made by Ranbaxy Laboratories Ltd. will be blocked at U.S. borders because of manufacturing failings at two of the Indian drugmakers' plants, regulators said.
"There is no evidence to date that Ranbaxy has shipped defective products'' and no reported harm, the U.S. Food and Drug Administration said today in a statement. The affected drugs are from Ranbaxy's plants in Paonta Sahib and Dewas, the agency said.
The action is separate from a continuing criminal investigation into the drugmaker, according to the FDA. The Justice Department said in a court motion in July that "allegations from reliable sources and supporting documents indicate a pattern of systemic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information.'' Ranbaxy has denied the allegations.
"With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality,'' said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, on a conference call today with reporters.
The FDA said Ranbaxy's responses to failings cited after inspections of the plants "were not adequate.'' The violations of "current good manufacturing practice'' ranged from inadequate sterile processing operations to inaccurate records.
Post a Comment