February 04, 2010 FDA warning letter about Ranbaxy facility in US cites "inadequate" response to agency's concerns by Mark Todoruk Details from an FDA warning letter concerning a Ranbaxy facility in the US, which the company previously revealed had been cited for violations of good manufacturing processes, were posted to the agency's website. In the letter, the regulator wrote that "it is apparent that Ranbaxy's attempts to make global corrections after past regulatory actions by the FDA have been inadequate." Ranbaxy reported in December that its subsidiary, Ohm Laboratories, received the warning letter in connection with inspections undertaken by the FDA in July and August last year at its liquid manufacturing facility in Gloversville, New York. The US regulator indicated in its communication that it had received a response to its concerns from the drugmaker in September, but noted "that [the response] lacks sufficient corrective actions." In addition, the warning letter is now reported to have contained a comment by the FDA stating that the agency "expects Ranbaxy to immediately undertake a comprehensive assessment of its global manufacturing operations to ensure that all sites manufacturing drugs for the US market conform to US requirements." Ranbaxy, which is majority-owned by Daiichi Sankyo, reportedly said on Thursday that it had no comment to add beyond the previous details it released about the matter on December 24, 2009. Reference
Very surprising for a company like Ranbaxy that has an almost cult following in the pharmaceutical industry for it's stellar loyalty to it's sales personal, most accurate company when it comes to FDA issues and noted for it's truthfulness in dealing with all associates and other companies it deals with, especially regulatory agencies. Can't be true, must be a lie being spread by Dr Reddy, another stellar Pharmaceutical wannabe. Woe is me, the Japs sure bought a piece of crap.
Well Said. We're all supposed to pound the pavement daily, exuding positivity about these fine products and fabulous company and there is a steady of reports like this making us look like fools. I'm sick of the salesforce being blamed for failures. Why can't these people do their jobs so we can do ours?
VERY well said above poster. They can't even keep their precious spray cans, with WD 40 nozzles that don't fit , in stock , so we can sell the out dated crap. Lets not forget Sotret, that will never come back after the sales force overcame out of stocks, no coverage, wrong NDC#s, and a multitude of other asshole issues that a competent company would have a staff to handle, but their answer was, blame the sales force. Ranbaxy will survive, under another name perhaps in the future. They are considered the worst of the worst Generic companies. Teva, a real generic company, form Isreal, is well respected among Pharmaceutical companies in general. Ranbaxy is a joke.
They are in big trouble again with the FDA. Falsifying data Agni. Just google Ranbaxy. The now owners from Japan are sending a Posse out to enforce the rules the FDA wants enforces that Ranbaxy continues to ignore. They still don't get it. This the US FDA, not the so called FDA of India that takes bribes and goes with the flow.
Who ever wrote this is such an ignorant moron. Ranbaxy's problems are coming to a close. The consent judgement is signed, the fines have been agreed, now starts the long road back. The news you are seeing is the culmination of the last 2 years of negotiations with FDA to resolve issues at Paonta and Dewas. Dummy.
The problem started with retooling in manufacturing. It does not happen all the time only when the company retask the curry mixer for drug. FDA got concerned when yellow curry powder is found in the machines.
Ignorant moron here, you assh;le. Which of the 180 day exclusive rights to a generic is Ranbaxy going to have to give up as part of the agreement, that has been worked out with the FDA for falsifying data. That is part of the deal ahole, Nexium maybe, or Diovan. Get with it Ranbay is on the FDA sh9t list idiot for lying, faking recods and various other violations. The only hope this indian piece of shit keeps afloat, if you get the joke, is the Japs come in and the work the problems themselves. Get it curry miester.
