After receiving two Form 483s in 2010 regarding repeated manufacturing problems, Johnson & Johnson’s McNeil Laboratories received a consent decree in April from the FDA that indefinitely closed one plant and placed oversight over two others. In a Form 483 given to Johnson & Johnson’s McNeil Laboratories by FDA inspectors at the company’s Fort Washington, Pa., plant on Dec. 9, 2010, investigators said they found several process validation violations.
The Food & Drug Letter