Troy Handed 483 With Repeat Observations

Troy Manufacturing was handed a Form 483 when an FDA inspection found repeat observations previously noted in 2006. For example, the Hazleton, Pa., facility does not have validated processes for manufacturing drug products, a repeat observation from the earlier inspection that has not been corrected, the Aug. 30, 2010, form says. According to another repeat observation, its process for cleaning equipment is not validated, and the company has not adequately verified that its cleaning methods are suitable. Troy has corrected all the observations and has sent the information to the FDA, Nick Pokoluk, Troy’s director of regulatory affairs and quality, said.
Drug GMP Report