FDA 483 - Syntenza Pharmaceuticals, LLC - March 12, 2020

An FDA inspection of Syntenza Pharmaceuticals, LLC in Edina, MN, revealed a significant deficiency in their postmarketing adverse drug experience reporting system. The firm lacked written procedures for surveillance, receipt, evaluation, and reporting of adverse drug experiences. Furthermore, the firm demonstrated a lack of awareness and involvement with procedures prepared and activities conducted by a contractor under the firm's name, indicating a critical breakdown in oversight.