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Four foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies. Read More
Three clinical investigators were cited for deviating from their investigational plans recently by the FDA for a litany of different reasons. Read More
The FDA handed a 10-observation Form 483 to a Texas manufacturer for sterility shortcomings, inadequate testing of products and deficient recordkeeping. Read More
In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More