CGMP Deviations at China’s Yino, Inc.

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 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.