“The recent Consent Decree of Permanent Injunction filed against Ranbaxy is groundbreaking in its international reach — it requires the company to make fundamental changes to its plants in both the United States and India,” Tony West, assistant attorney general for the U.S. Justice Department’s Civil Division.
Problems uncovered through the investigation by the Justice Department and FDA include failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs didn’t meet their specifications; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date.
The government also found that Ranbaxy submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed, according to the U.S. Justice Department’s statement.
Read FDA’s Press Release and a news account with more details. Go to: www.gmptrainingsystems.com/resources
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