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The FDA slapped three drug manufacturers — including two Chinese firms — with warning letters after the agency’s inspections revealed a wide range of issues at the facilities, such as adulterated products and the lack of a quality unit. Read More
The FDA hit Akorn with a lengthy Form 483 with 13 observations for failing to properly safeguard against microbiological contamination and to monitor conditions in aseptic processing areas following April/May inspections of its Decatur, Illinois, facility. Read More
The FDA warned API manufacturer Yuki Gosei Kogyo about major data integrity violations observed during a Nov. 13-17 inspection of its facility in Fukushima, Japan. Read More
The FDA hit Akorn with a lengthy Form 483 with 13 observations for failing to properly safeguard against microbiological contamination and to monitor conditions in aseptic processing areas following April/May inspections of its Decatur, Illinois, facility. Read More
The FDA warned API manufacturer Yuki Gosei Kogyo about major data integrity violations observed during a Nov. 13-17 inspection of its facility in Fukushima, Japan. Read More
The FDA issued a Form 483 to active pharmaceutical ingredient manufacturer IDT Australia citing quality shortcomings and other deviations observed during a December inspection of its Boronia, Victoria, facility. Read More
The FDA sent a warning letter to compounder Gipsco Investment cautioning that it’s not exempt from the agency’s oversight and was producing adulterated and misbranded products. The action stems from a June 2017 inspection of the Cleveland, Ohio, facility. Read More
Edge Biologicals was hit with a Form 483 for violations at its Memphis, Tennessee facility, including inadequate environmental monitoring, poor complaint handling and incomplete recordkeeping observed during a March inspection. Read More