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The FDA hit a Levittown, Pennsylvania drug manufacturer with a Form 483 after an inspection turned up inadequate stability testing and other violations. Read More
PaxVax Berna netted itself a Form 483 after an FDA inspection revealed inadequate testing and tardy deviation reports by its Thorishaus, Switzerland facility. Read More
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