The Food and Drug Administration has issued a stern warning to pharmaceutical manufacturer Warner Chilcott Company, LLC in Fajardo for not taking sufficient corrective action related to its birth control pill production.
A letter sent last week follows an inspection the agency conducted last summer at the plant, upon which it detected “significant violations” to good manufacturing practices resulting in adulterated birth control products, specifically Ovcon and Ethinyl Estradiol tablets.
Among other things, the agency said the products had failed to pass required stability tests, which directly affect the product’s shelf life and expiration date. Warner Chilcott began making the products in 2005.
“For example, the stability history of your drug product (Ovcon 50) suggests that since your acquisition of the product in 2005 … your quality control unit has failed to exercise its responsibility to assure that your product meets its predetermined specifications throughout its shelf life,” the FDA said in the letter dated March 8.
The plant responded to the FDA’s concerns in August 2011, but apparently Warner Chilcott did not take sufficient corrective actions, which included creating new packaging to address the shelf-life issue. Furthermore, the company pulled the product off the market in mid-2011.
“Your quality unit failed to ensure that the drug product quality issues were adequately evaluated. Specifically, your quality unit failed to effectively evaluate available developmental and technical transfer data that may impact the quality attributes of products that you manufacture,” the FDA said.
Warner Chilcott has 15 working days to address the FDA’s concerns.