Company: Abbott Laboratories
Date: 7/19/02
Product: Drug products including Biaxin and Meridia
FDA compared the MedWatch forms in your computer to your paper files, and this comparison revealed inaccurate data in serious and unexpected adverse drug experience reports submitted to FDA. These inaccurate reports are a violation of 21 CFR 314.80(c)(1)(i).
FDA District: Chicago District Office
