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Shuttered Boehringer Ingelheim subsidiary Ben Venue continues to create quality headaches for the German manufacturer with the recall of a chemotherapy drug due to a container defect. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More
Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn’t manufactured in compliance with FDA GMPs, creating another quality headache for the Indian drugmaker. Read More
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates. Read More
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials, and nine lots due to particulates in vials. Read More
Indian regulators have issued a uniform set of procedures that state drug authorities should follow when inspecting plants for GMPs and issuing certificates of pharmaceutical product (COPP) that clear drugs for export. Read More
Impax received two Form 483s less than a week apart for poor inspections of two manufacturing facilities, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
A U.S. senator is urging the FDA to act on a potential shortage of the antibiotic doxycycline while he mulls legislation that would allow the agency to step in sooner to deal with shortages. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More
The FDA was not happy that Elite Laboratories’ quality unit failed to validate and review various product batches before distribution, landing the generic drug maker a Form 483. Read More