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Injectable sterile drug manufacturer Pharmaceutics International received a Form 483 for its failure to adequately investigate particulates in products and conducting design inputs for its combination product. Read More
Agila Specialties failed to conduct complete investigations into customer complaints, forcing the FDA to give the Indian manufacturer with a Form 483. Read More
Identical results on different batch tests and other data integrity problems resulted in a Form 483 for Chinese active pharmaceutical ingredient (API) manufacturer Changzhou Qianhong Bio-pharma. Read More
India’s national drugs authority is again surveying pharmacists and testing drug samples in an effort to better grasp the extent of the country’s counterfeit and substandard drugs problem. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
The FDA unveiled a broad plan that will change the way it inspects drugmakers, approves recalls, issues and reviews enforcement decisions, screens imports and tests products for quality, with drugmakers likely to start feeling the impact by the end of 2015. Read More
FDA investigators will be able to photograph most areas of a facility during an inspection, including product labels and visible contamination of materials, according to a final guidance issued last month. 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
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