The QMN Weekly Bulletin
Sept. 16, 2011
| Vol.
3 No.
37
A recent Dr. Reddy’s Laboratories recall of generic Zocor did not stem from shipping byproduct 2,4,6-tribromoanisole (TBA), as the FDA first reported, the company told DGR.
As two investigations into Boston Scientifics’ Cardiac Rhythm Management (CRM) division end, the devicemaker is preparing to defend itself against safety allegations by the FDA.
Requests for enhanced adverse event reporting have spurred Australia’s Therapeutic Goods Administration (TGA) to promise new online reporting forms for medical devices.
The U.S. Food and Drug Administration warned Luitpold Pharmaceuticals to fix significant problems at a plant temporarily shut down in April after inspectors found violations.
A Boehringer Ingelheim application for two new projects in Ridgefield, Conn., is before local authorities.
Strides Arcolab said the U.S. FDA recently inspected its oral dosage forms plant in Bengaluru, India, as part of a GMP audit.
Alcon is moving roughly 100 jobs from Atlanta, its headquarters city, to Fort Worth, in a consolidation of eye-care operations.
To streamline further, Merck, plans to cut as many as13,000 jobs by the end of 2015, with up to 40 percent of reductions in the U.S.
Teva Pharmaceutical announced that on Sept. 9 it received a close-out letter from the FDA formally declaring that the company successfully addressed issues raised in a warning letter received on Jan. 31.
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