ECI Pharmaceuticals Warned About Listing Violations

FDA is warning ECI Pharmaceuticals, Fort Lauderdale, FL, about violations in information the company provided to the agency’s electronic drug registration and listing system. A just-released 2/3 Warning Letter says the firm selected an incorrect active ingredient, conjugated estrogens, to be listed in the electronic file for its drug products “esterified estrogens and methyltestosterone” while listing esterified estrogens and methyltestosterone on two separate NDC (National Drug Code) numbers.

The letter cites two previous FDA communications with the company that notified it of the listing deficiencies and then notified it of removal from the agency’s online NDC directory.

FDA says conjugated estrogen and esterified estrogens “are different and not equivalent.”

ECI was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the work.