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The FDA has cited five U.S.-based drug compounders in as many weeks, with most of the complaints focusing on sterility issues, although questions of adulteration and issuing unapproved drugs also surfaced. Read More
The FDA has stepped up its enforcement efforts in Taiwan and mainland China in the past month, issuing warnings to two Taiwanese drugmakers and two Chinese companies. Read More
The FDA has faulted two compounders for neglecting to apply quality controls to the production of their sterile drugs, pummeling one of the compounders with 13 citations. Read More
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