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The FDA issued a warning letter to a Concord, Ontario-based over-the-counter drug facility for significant violations of current good manufacturing practices—its third trip through the agency’s ringer. Read More
Laboratoires Claires drew a warning letter from the FDA for shoddy out-of-specification investigations and other violations at its Pontoise, France facility. Read More
Four U.S. drug manufacturers were handed Form 483s for quality violations observed at their facilities, such as issues with quality monitoring, facility maintenance and unqualified handling of quality responsibilities. Read More
The FDA hit Minnesota generic drug manufacturer Upsher Smith Laboratories with a Form 483 over cleaning and batch production violations at its Plymouth facility. Read More