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# CGMP Issues at China’s Yuyao Yijia Daily Chemical Co.
- URL: https://www.fdaweb.com/cgmp-issues-at-chinas-yuyao-yijia-daily-chemical-co/
- Published: 2021-01-26T12:00:00.000Z
- Updated: 2026-09-14T16:44:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148522

FDA says its review of records and other information submitted by Yuyao Yijia Daily Chemical Co., Ningbo, China, a registered manufacturer of over-the-counter drug products, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yuyao-yijia-daily-chemical-co-ltd-610487-01222021?ref=fdaweb.com) identifies specific violations as: 

- failing to have for each batch of drug product appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release;
- failing to conduct at least one test to verify the identity of each component of a drug product;
- failing to establish and follow an adequate written testing program designed to access the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
- failing to establish adequate written responsibilities and procedures applicable to the quality control unit.

The letter recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements. It also recommends that the consultant perform a comprehensive audit of the firm’s entire operations for CGMP compliance and evaluate the completion and efficacy of the company’s corrective and preventive actions before it pursues resolution of the firm’s compliance status with FDA.

FDA placed the firm’s products on an import alert 9/23/20\. Yuyao Yijia was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with any additional information for FDA to consider as it continues to assess the company’s activities and practices, along with a timetable for completing the actions.