Ranbaxy vows to correct FDA violations
NEW YORK —Ranbaxy Laboratories hit a speed bump when the Food and Drug Administration announced that it would ban the import of drugs made at two of its plants in India, into the United States.
The FDA issued two warning letters to the Gurgaon, India-based generic drug maker and an import alert for generic drugs produced at the two plants on Sept. 16, citing deviations from U.S. current good manufacturing practice requirements and deficiencies in the company’s drug-manufacturing process. By Sept. 18, the list of products affected by the import alert had grown to 33 drugs and six active pharmaceutical ingredients, and U.S.-based competitor Mylan’s stock rose when analysts said Ranbaxy’s problems would cause it to take some of the Gurgaon, India-based generic drug maker’s market share.
Ranbaxy has accepted the FDA’s warnings and said it will work to fix the problems.
“We are looking at how we can work with the FDA to satisfactorily correct the shortcomings,” said Venkat Krishnan, vice president of Ranbaxy USA and regional director for North America. “We will continue our efforts to work with the FDA to answer their questions and resolve the issues as quickly as possible.”
The specific problems at the two plants, which the FDA documented early this year, included inadequate measures to prevent pharmaceutical cross contamination and inadequate batch production and control records at the Dewas plant, and inaccurate written records of the cleaning and use of major equipment at the Paonta Sahib plant, where the FDA also cited cGMP violations in 2006.
Still, the FDA did not find any problems with drugs manufactured at the plants and recommended that patients continue taking them. It also did not find similar problems at Ranbaxy’s other plants and said they did meet cGMP requirements.
“We’re just a little concerned that they took the pathway to put us on an embargo, which we don’t think is the solution to the problem,” said Jim Meehan, vice president of sales, marketing and distribution. “There’s nothing wrong with our products—the FDA has said that.”
The company has hired pharmaceutical consultancy PAREXEL International to address the problems at the two plants and retained the legal services of former New York mayor Rudy Giuliani to resolve the issues with the FDA.
For the time being, Krishnan said, restoring confidence in Ranbaxy’s products in the United States will require getting the embargo lifted.
Wegmans begins trial of self-checkout lanes in New York store
ROCHESTER, N.Y. Wegmans is testing four self-checkout lanes for the first time near company headquarters at its Penfield, N.Y. store based on consumer demand, according to published reports.
We were never in a rush to introduce self-checkout,” Jo Natale, Wegmans spokeswoman, told the Rochester Democrat & Chronicle. “We had never seen one we liked or offered features for customer convenience.”
Wegmans stores close all photography centers
ROCHESTER, N.Y. Supermarket chain Wegmans is closing down its photo operations, reports this week said. After more 20 years serving its communities with photo services, the company will no longer offer full-service in-store photo development.
The closures affect 12 stores in Wegmans’ Rochester market. This will affect 18 full-time employees and 52 people who work in photo part-time in Rochester, the company said, as well as 63 full-time photo employees and 173 part-timers companywide. Wegmans has said it will try to make adjustments to keep some of those employees in the company.
So far in the past year, Wegmans has closed 9 of its photo departments. The company has said that the closures are largely due to the growing popularity and accessibility of digital photography.