UIP Recommended for Approval After Form 483

An FDA district office has submitted a recommendation of approval to the Center for Drug Evaluation and Research for the University of Iowa Pharmaceuticals (UIP) to manufacture an aseptically filled sterile prescription drug product for a commercial client, according to a university statement.

The recommendation comes after UIP received a Form 483 in April that cited its Iowa City plant with sanitization process failures.

UIP rectified the observations by purchasing a fog system for its sterile products department and using sporicidal agents almost exclusively during the sanitization process, according to UIP Quality Manager Mark Feldick.
Drug GMP Report