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Ranbaxy Labs Issued With FDA Consent Decree

By Tim Sandle
Posted Feb 3, 2012 in Health
Ranbaxy Laboratories entered into a Consent Decree with the FDA on January 25, 2012 wherein they agreed to pay a $500 million fine and accept changes to plants both within the US and India. This related to issues associated with the the falsification of data and submitting data when no samples were tested.
The FDA have filed a consent decree for a permanent injunction that prevents the Indian drugmaker from making medicine for the US market until certain facilities meet US standards.
The plants in India are at Paonta Sahib, Batamandi and Dewas, which were placed on an FDA import alert in 2008.
In addition to the false dat, the FDA have also found that there has been a failure to keep written records showing that drugs had been manufactured properly; a failure to investigate evidence indicating that drugs did not meet their specifications; a failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; a failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date.
Pretty long list and evidence of a company attempting to act outside of best practices.
To view the FDA statement on this subject go to: FDA