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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
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
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
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant good manufacturing practice violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More