Ranbaxy Labs awaits FDA re-inspection

This is not good. Ranbaxy screwed up on 30 drug product studies and then hired a bunch of high paid reg. affairs people to do the paperwork to cover up their mistakes. They have definitely learned from this experience both in how to improve the documentation traceability for their drug product studies and more importantly, unfortunately, how to cover up mistakes in the future. Don’t let the fact that this company sell their stuff in Japan and Europe fool you into think their product has the quality require for north america because it doesn’t. The knowledge and experience of health authority reviewers for these markets are not in the same class as FDA and Health Canada HPFBI. I should know I’ve made (or reviewed) submissions for both generics and brand companies to all these markets

I would like to say that its problematic to ranbaxy, as being a long experience in the drug manufacturing, why its happing with Ranbaxy to have a 483s .

Regards
R C Pantola