Abbott Molecular Gets 483 Listing Six Observations

March 11, 2010
Abbott Molecular’s Des Plaines, Ill., facility received six observations related to its hepatitis B virus (HBV) in vitro diagnostic. Abbott doesn’t have complete procedures to accept or reject finished device production runs, lots or batches, and its out-of-specification products weren’t adequately controlled, according to a Form 483 that stems from a June inspection. The company has implemented corrective actions and is working to ensure all requirements have been met, Abbott spokesman Don Braakman said. It also has submitted all appropriate amendments to the HBV PMA, which are under review.
The GMP Letter