Ranbaxy Withdraws 27 Approved ANDAs Under Consent Decree

Ranbaxy has withdrawn its approved ANDAs for 27 U.S. drugs to focus on other applications and fixing good manufacturing practice deviations that prompted a consent decree earlier this year.

The consent decree specifies that Ranbaxy must never submit another application to the FDA for the withdrawn drug products and must never transfer the ANDAs to a third party. The products are no longer marketed, so the move will have a negligible impact on the company, it said.

Ranbaxy entered into the consent decree in January to resolve lingering manufacturing problems at two Indian plants. The decree commits the company to “corrective steps” to address issues cited in two Sept. 16, 2008, warning letters and an import alert for 30 generic drugs.

During inspections, the FDA found several GMP violations, including failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating drugs did not meet specification; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs to prevent cross-contamination and inadequate aseptic procedures.

Are you ready for your next inspection? Each year, the FDA makes adjustments to its inspection processes and policies. This year is no exception.

For example, the FDA now advises its inspectors to not ask for permission but take their cameras into facilities and take pictures as they see fit.  If a firm complains, the new policy is for the inspector to contact the firm’s legal counsel and advise the district management immediately.

This change and many more are to be discussed at FDAnews’ Seventh Annual FDA Inspections Summit. Year after year, the crème de la crème of the industry make it their business to attend this conference and tap into the cumulative knowledge of top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs (and more)!