FDA Warns US Specialty Formulations for Unsanitary Conditions

BETHLEHEM – Federal authorities say an early stage pharma company housed in the Ben Franklin Technology Partners' TechVentures in Bethlehem has been making one of its drug compounds in unsanitary conditions.

US Specialty Formulations LLC received a warning Letter last month from the U.S. Food and Drug Administration, which says the company's product, Actril, failed to undergo a proper disinfecting process. The FDA also says the company neglected to provide pertinent label information, such as "This is a compounded drug," on the product. The infractions violate the federal Food, Drug and Cosmetic Act, the FDA says.

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