FDAnews Drug Daily Bulletin

Apotex Warning Letter Casts Doubt on Company’s Process Controls

March 28, 2013
An imprecise media fill protocol and poor probes into speckled tablets have landed Apotex a warning letter in which the FDA questions the heft of the generic-drug maker’s process controls. The letter, posted Wednesday, follows a mid-August inspection of two of the company’s Canada facilities that found “significant violations” of current good manufacturing practices (cGMP). It was also prompted, in part, because Apotex’s response to the findings fell short, the letter states.
Washington Drug Letter