FDA 483 - Toray Research Center, Inc. - June 09, 2023

An FDA inspection of Toray Research Center, Inc. Nagoya Laboratory, a contract manufacturing laboratory, revealed deficiencies in their quality control unit's procedures. The firm's written procedure for handling unexpected occurrences and documenting deviations was not fully followed. This resulted in multiple instances where deviations, specifically delayed stability test completions, were not documented in a timely manner.