483
Toray Research Center, Inc.Toray Research Center, Inc. – FDA 483, Jun 9, 2023
Record Details
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.
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ID · 47d42da8-8f1e-4117-bd86-65ac7aa96bf2
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