Warner Chilcott Gets Warning Citing Stability Spec Failures

The FDA wants Warner Chilcott’s Fajardo, Puerto Rico, plant to do a retrospective review of its stability program for all approved products on concerns that some may not meet specifications throughout their shelf life, according to a recent warning letter. The stability history of Ovcon 50 (norethindrone/ethinyl estradiol), an oral contraceptive, suggests that since Warner’s acquisition of the product in 2005, the quality unit has failed to assure it meets specifications for the entire shelf life, according to the March 8 letter posted online Tuesday.
Drug Industry Daily