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Sunrider Manufacturing of Torrance, California drew a Form 483 from the FDA for incomplete complaint investigations and data integrity violations at its OTC manufacturing facility. Read More
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