FDA Warns Two Drug Companies About Manufacturing Practice Violations

In warning letters posted online March 13, the Food and Drug Administration told Warner Chilcott Co. and Wintac Ltd. that FDA inspections revealed the two companies had not complied with current good manufacturing practices (cGMPs).

FDA said that as a result of the inspections, products made by the companies were considered “adulterated” under the Federal Food, Drug, and Cosmetic Act.

Warner Chilcott Letter.

In a March 8 letter, FDA told Warner Chilcott that it found violations during an inspection of the Fajardo facility in Puerto Rico that ended July 29, 2011. Warner Chilcott responded about the violations on Aug. ...