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Florida drug company hit with Consent Decree

October 11th, 2011 · No Comments · Uncategorized

The U.S. FDA announced that the District Court for the Middle District of Florida entered a consent decree that prohibits Hill Dermaceuticals, Inc., and Hill Labs, Inc. from introducing adulterated drugs into interstate commerce.

This Consent Decree describes numerous deviations from current good manufacturing practice (cGMP) for drugs documented during the FDA’s inspections of Hill. FDA  further alleges that Hill has, on more than one occasion, submitted untrue statements in support of submissions to the FDA. These falsified submissions are evidence of persistent data integrity problems at Hill.

Read FDA’s Press Release. Go to: www.gmptrainingsystems.com/resources
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