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API manufacturer Jiangsu NHWA Pharmaceutical drew a warning letter from the FDA for inadequate laboratory protocols and investigations into foreign particles in batches of active ingredients, following an inspection of its Jiawang site in Xuzhou. Read More
Positron emission tomography (PET) drug manufacturer SOFIE drew a warning letter from the FDA for fungal contamination in ISO 5 areas at its facility in Sanford, Florida. Read More
A generic drug manufacturer in the Bahamas drew a warning letter from the FDA and was placed on an import alert for cGMP violations at its Freeport City facility, including inadequate validations and testing. Read More
The FDA named Indian drugmaker Torrent Pharmaceuticals as a target of its investigation into nitrosamine impurities and issued the company a warning letter for repeat violations at its Indrad, Gujarat plant. Read More
The ISO 7 cleanrooms had counter tops made of a black material that “may be difficult to clean and sanitize,” creating contamination risks, the investigator found. Read More
The FDA issued a warning letter to Indian API and generics manufacturer Glenmark for multiple violations at its Baddi, Himachal Pradesh plant, including incomplete investigations of complaints. Read More