Watson 483
This article was originally published in The Tan Sheet
Executive Summary
Firm says it is taking appropriate steps to remedy FDA observations in a 483 good manufacturing practices report regarding laboratory test messages and documentation procedures after an inspection of its Corona, Calif. manufacturing plant March 31 through May 6. Watson recently received ANDA approval for 2 mg and 4 mg nicotine polacrilex gum, equivalent to GlaxoSmithKline's mint-flavored Nicorette (1"The Tan Sheet" Aug. 2, 2004, In Brief)...