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French API Maker Rapped For Poor Facility Conditions

October 18, 2013
French active pharmaceutical ingredient (API) maker Produits Chimiques Auxiliaires et de Synthese received a Form 483 for chipped paint and other deteriorating conditions in the manufacturing area of the company’s Limay, France, facility. During a June inspection, FDA investigators found unsanitary conditions near the main processing areas, including two “unclean, damaged” overhead lights above finished product drums, the form reads.
Drug GMP Report