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The FDA cited Sovereign Pharmaceuticals for quality and other failures observed during a Dec. 11-19 inspection of its facility in Fort Worth, Texas—including its failure to ensure the quality of pilot or exhibit batches. Read More
Quality violations at Tedor Pharma’s Cumberland, Rhode Island site netted the drugmaker a Form 483 from the FDA for inadequate testing, cleaning and calibration procedures. Read More
A Gujarat, India finished drug manufacturer drew a warning letter from the FDA after an inspection turned up serious violations at its facility, including shredded and falsified data. Read More
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