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# Chengdu Records Review Finds CGMP Deviations
- URL: https://www.fdaweb.com/chengdu-records-review-finds-cgmp-deviations/
- Published: 2025-02-11T12:00:00.000Z
- Updated: 2026-09-14T14:52:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158638

An FDA review of records supplied by Chengdu Innovation Pharmaceutical Co. in Sichuan Sheng, China, following an agency 4/29/2024 request, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 2/5 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-innovation-pharmaceutical-co-ltd-698786-02052025?ref=fdaweb.com) says specific deviations were:

- failure to test the identity of each lot of incoming production material; and
- failure of the firm’s quality unit to establish a system to release or reject raw materials, intermediates, packaging, and labeling materials.

FDA recommends that Chengdu engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency placed the firm’s products on a 1/17 Import Alert.

Chengdu was told to correct any deviations promptly and to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.