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

Source: https://www.keypedia.com/records/483/toray-research-center-inc/47d42da8-8f1e-4117-bd86-65ac7aa96bf2

> FDA 483 for Toray Research Center, Inc. on June 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Toray Research Center, Inc.
- Inspection Date: 2023-06-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/toray-research-center-inc/4fcf0854-2417-486a-b703-a2571a299f29

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1