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FDA investigators are finding unprecedented data integrity problems at contract and active pharmaceutical ingredient manufacturers, even after they have been audited by the firms that hired them, an FDA official said. Read More
The FDA warned a partially defunct compounder for a multitude of quality violations such as using soap and water to clean parts of the production facility. Read More
Mylan recalled 15,966 bottles of the blood pressure drug metoprolol succinate tablets due to a product mix-up, the third recall in the past five months involving generic versions of AstraZeneca’s Toprol-XL. Read More
FDA investigators are finding unprecedented data integrity problems at contract and active pharmaceutical ingredient manufacturers, even after they have been audited by the firms that hired them, an FDA official said. Read More
The FDA warned a partially defunct compounder for a multitude of quality violations such as using soap and water to clean parts of the production facility. 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 yesterday. Read More
The FDA did not buy a manufacturer’s rationale that its quality lapses are due to different Chinese standards, resulting in a warning letter for a slew of violations. Read More
The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. 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 did not buy a manufacturer’s rationale that its quality lapses are due to different Chinese standards, resulting in a warning letter for a slew of violations. Read More
The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More