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The FDA issued a warning letter to Pharmasol over violations at two of its drug manufacturing facilities, including problems with quality oversight and leaky stability samples. Read More
The FDA flagged four U.S. facilities and one in Switzerland for quality and other violations observed during agency inspections—from inadequate testing to incomplete records. Read More
The FDA issued warnings to one Indian drugmaker, one Canadian manufacturer and four U.S. facilities for a variety of violations including falsified or missing data. Read More
Italian regulators suspended a drugmaker’s marketing authorization following an inspection that revealed serious quality violations at its facility in Cellole—about 30 miles northwest of Naples. Read More
The FDA issued a warning letter to Nationwide Laboratories over repeated CGMP violations at its Iselin, New Jersey facility, including failing to monitor its contractors. Read More
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