We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued a warning letter to Zhuhai United Laboratories, an active pharmaceutical ingredient firm based in Zhuhai, China, taking the facility to task for failure to investigate out-of-specification results and to correct critical CGMP deviations. Read More
The FDA said the company failed to explain why it distributed the contaminated lots or to address the need for improvements in its quality system. Read More
The FDA sent a warning letter to Connecticut-based drugmaker Milbar Laboratories for quality deficiencies and failure to investigate out-of-specification batches. Read More
The FDA issued Form 483s to U.S. and foreign drugmakers, citing violations for sanitation issues, unreliable data and nonconformances, among other observations. Read More
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