The United States filed a consent decree Wednesday for permanent injunction against Indian generic drug manufacturer Ranbaxy Laboratories Ltd., in the U.S. District Court for the District of Maryland.
Ranbaxy – Failures Galore
The U.S. Department of Justice statement said the government uncovered several problems with Ranbaxy’s drug manufacturing and testing in India and at facilities owned by its U.S. subsidiary, Ranbaxy Inc.
These problems allegedly include:
* Failure to keep written records showing that drugs had been manufactured properly
* Failure to investigate evidence indicating that drugs did not meet their specifications
* Failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination
* Failure to have adequate procedures to prevent contamination of sterile drugs
* Failure to adequately test drugs to ensure that they kept their strength and effectiveness until their expiration date
The U.S. government has also determined Ranbaxy submitted false data in drug applications to the Food and Drug Administration (FDA), including backdating of tests and submitting of test data for which no test samples existed. Continue reading »
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