At the end of a busy month, in the US and overseas, for good manufacturing practice (GMP) enforcement actions the US Food and Drug Administration (FDA) has hit out again at quality problems.
The FDA accuses Florida-based Hill Dermaceuticals and Hill Labs of filing untrue statements to back submissions. Following the falsified submissions, which the FDA says show persistent data integrity problems, and earlier warning letters the agency has filed a permanent injunction against Hill.
“Because this company continued to violate cGMP regulations and falsify information on submissions to FDA, the agency took this action in an effort to protect consumers”, Dara Corrigan, the FDA's associate commissioner for regulatory affairs, said.
The consent decree entered into by the FDA bans both Hill companies and individuals Jerry Roth and Rosario Ramirez from introducing adulterated drugs into interstate commerce. Aspects of the FDA’s Application Integrity Policy have also been included to ensure submitted data is authentic.
Hill produces its own topical prescription drugs, such as DermaSmoothe and DermOtic, and works as a contract manufacturer for Galderma Laboratories. The FDA said Galderma outsources production of Tri-Luma Cream and Capex Shampoo to Hill.
Chinese API warning letter
For the second time this month the FDA has sent a warning letter to an overseas producer of active pharmaceutical ingredients (API). China-based Sichuan Pharmaceutical is the latest to be targeted by the FDA after inspectors found it failed to have procedures to prevent cross-contamination.
Inspectors made the observation following a June 2010 visit to a plant in Pengzhou, Sichuan in central China. The plant switched to produce a different product but Sichuan Pharmaceutical failed to adequately decontaminate the facility.
“In your response to this letter include your plans for decontamination, renovation, and reactivation, if appropriate, of your facility including the decontamination agent, decontamination plans, analytical methodology for environmental and product testing”, the FDA said.