The FDA and Hill Dermaceuticals have entered into a consent decree that prohibits the Florida drugmaker from distributing adulterated drugs. The action is formally against Hill Dermaceuticals and Hill Labs. Also named are president Jerry Roth and Rosario Ramirez, whose title is not given.
According to an FDA statement, the legal action is prompted by "numerous deviations from current good manufacturing practice," as well as the submission of "untrue" and "falsified" information in regulatory submissions. "These falsified submissions are evidence of persistent data integrity problems at Hill," the statement says.
The agency has amassed GMP-violation data from multiple inspections spanning 2004 to 2010, says the U.S. Department of Justice.
Hill was the recipient of two warning letters in 2009, one in April (FLA 09-13) for poor master production and control practices and recordkeeping, the other in August (unnumbered) for making and marketing unapproved and misbranded prescription drugs. The company also made our 2009 list of Top 12 GMP Violations.
Continued GMP violations and falsified information led the agency to take the consent decree action. Terms prevent Hill from introducing adulterated drugs into interstate commerce, and it includes elements of the FDA's Application Integrity Policy, which helps ensure the authenticity of submitted data. "The FDA will verify the adequacy of Hill's corrective actions," says the statement, which includes no mention of a fine.
- here's the consent decree release
- see the DoJ statement