FDA 483 - Molecular PharmaGroup - December 11, 2023

An FDA inspection of Molecular PharmaGroup, an outsourcing facility in New Providence, NJ, revealed two significant observations. The firm failed to include required information on its drug product labels, such as the facility's address and a list of ingredients. Additionally, Molecular PharmaGroup did not submit a report to the FDA identifying products compounded during a previous six-month period.