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# CGMP Deviations at China’s Yino, Inc.
- URL: https://www.fdaweb.com/cgmp-deviations-at-chinas-yino-inc/
- Published: 2019-09-03T12:00:00.000Z
- Updated: 2026-09-15T01:47:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144905

An FDA 3/18-3/22 inspection at Yino, Inc., Chongqing, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). An 8/12 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yino-inc-578566-08122019?ref=fdaweb.com) says the deviations were: 

- failing to transfer all quality or regulatory information received from the API manufacturer to Yino customers; and
- failing to establish, document, and implement an effective system to manage quality.

The letter says the agency has not received a response to the FDA-483 for corrective actions for the inspection observations.

FDA says it strongly recommends that Yino engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

The firm was placed on an import alert 8/1.

Yino was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.