FDA Threatens Import Refusal for Italian API Maker
The Food and Drug Administration threatened to refuse imports of active pharmaceutical ingredients (APIs) made by a company in Italy because of violations of current good manufacturing practice (CGMP) requirements, in a warning letter dated July 7. FDA says employees…
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of Trifarma’s facility in Rozzano, Italy deleted from its computers data on testing of APIs that were destined for the United States. That may have been because the facility allowed all of its laboratory employees full access to its computer systems, said FDA. The agency said this isn’t the first time this type of violation has cropped up at a Trifarma facility, noting similar issues it found at a different Trifarma plant in November 2013. FDA said failure to correct the violations may result in APIs from the Rozzano facility being placed on import alert.