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The FDA issued an untitled letter to Arizona-based R3 Stem Cell for marketing unapproved stem cell products with claims to treat serious illnesses such as Lyme disease, Parkinson’s, diabetes, stroke, kidney failure and ALS. Read More
The firm failed to conduct studies to determine if construction materials for a distribution loop and holding tank had an effect on water quality over time. Read More
Italian regulators suspended a drugmaker’s marketing authorization following an inspection that revealed multiple serious quality violations at its facility in Cellole—about 30 miles northwest of Naples. Read More
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