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# API Deviations at Henan Lihua Pharmaceutical
- URL: https://www.fdaweb.com/api-deviations-at-henan-lihua-pharmaceutical/
- Published: 2018-06-26T12:00:00.000Z
- Updated: 2026-09-15T00:15:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141768

A 12/11-12/14/17 FDA inspection at two Henan Lihua Pharmaceutical facilities in Henan, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients. A 6/12 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm611369.htm?ref=fdaweb.com) says specific deviations were: 

- failure of the firm’s quality unit to review and approve all appropriate quality-related documents; and
- failure to maintain complete data derived from all laboratory tests conducted to ensure that the firm’s active pharmaceutical ingredients comply with established specifications and standards.

“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,” FDA says. “We acknowledge that you committed to using a consultant to assist in meeting FDA requirements.” The company was told to provide a comprehensive investigation into the extent of inaccuracies in data records and reporting; a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and a management strategy for the company that includes the details of its global corrective and preventive action plan.

FDA placed the company on an import alert 3/29\. Henan was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.