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# CGMP Violation Found in Toyobo Inspection
- URL: https://www.fdaweb.com/cgmp-violation-found-in-toyobo-inspection/
- Published: 2021-08-24T12:00:00.000Z
- Updated: 2026-09-14T17:11:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150002

An FDA 2/15-2/25 inspection at Toyobo, Co., Shiga, Japan, found violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/19 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/toyobo-co-ltd-614177-08192021?ref=fdaweb.com) says the specific violation was failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs Toyobo manufactures. It acknowledges the company’s use of a consultant and requests **(1)** a comprehensive investigation into the extent of inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and **(3)** a management strategy for the company that includes the details of a global corrective and preventive action plan.

Toyobo was told to take steps to promptly correct the violation and prevent its recurrence, with a schedule for completing the steps.