date:Sep 12, 2012
whether corrective actions have been implemented and compliance achieved.
And the costs could soon add up, points out FDA Imports.
If for example, the FDA inspects a US factory and finds the manufacturer in violation of cGMPs and issues a form 483, the FDA will bill the firm hourly for the time it takes to review its written response to the 483, to prepare for travel, to travel to and from the facility for re-inspection, to conduct the re-inspection, and to prepare any subsequent reports post r