FDA Says Compounder May Resume Production

The FDA cleared an Arkansas drug compounder, Cantrell Drug Company, to resume operations, saying it appeared to have resolved the issues that led to a consent decree of permanent injunction.

The U.S. District Court for the Eastern District of Arkansas handed down the consent decree in April, prohibiting the firm from manufacturing or distributing drugs because of unsanitary conditions and CGMP violations that caused its drugs to be adulterated.

The FDA inspected the facility from Aug. 13-22. The company responded to the Form 483 observations on Aug. 24 and provided more information in the following weeks to address the agency’s concerns.