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# CGMP Deviation at Yuki Gosei Kogyo
- URL: https://www.fdaweb.com/cgmp-deviation-at-yuki-gosei-kogyo/
- Published: 2018-07-31T12:00:00.000Z
- Updated: 2026-09-15T00:23:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142002

An 11/13-11/17/17 FDA inspection at the Yuki Gosei Kogyo drug manufacturing facility in Fukushima, Japan, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API), according to a 7/17 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm614609.htm?ref=fdaweb.com). The significant deviation cited in the letter was failure to maintain complete data derived from all laboratory tests conducted to ensure that API complies with established specifications and standard.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the letter says. “We strongly recommend that you retain a qualified consultant to assist in your remediation.”

The company was told to submit **(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 including details of its global corrective and preventive action plan.

Yuki also was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.