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The FDA has handed Boehringer Ingelheim a 10-observation Form 483 for delays with a field alert report, as well as sanitation and sterilization procedures at a site in Germany. Read More
The FDA is calling out a Taiwanese drugmaker for a slew of GMP violations circling its quality control unit's written procedures, rendering its products adulterated. Read More
British inspectors turned up a laundry list of apparent violations at two Indian manufacturers, leading them to block drugs from one of them and impose restrictions on the other’s GMP certificate. Read More
Shortly after receiving an FDA warning letter for alleged major quality deficiencies, an Indian vaccine maker was slammed for data integrity issues and GMP violations by the World Health Organization. Read More
A Janssen production plant that turned heads for its continuous production line was handed a 483 two months prior to switching the line from batch production. Read More
Two compounders are facing FDA warning letters for sterility concerns, with one company being pummeled for numerous other quality deficiencies. Read More