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# CGMP Deviations in Chengdu Records Review
- URL: https://www.fdaweb.com/cgmp-deviations-in-chengdu-records-review/
- Published: 2025-09-23T12:00:00.000Z
- Updated: 2026-09-14T15:22:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159915

An FDA review of records submitted by Chengdu Brilliant Biopharmaceutical Co. in Shuangliu District, Chengdu, Sichuan, China, in response to an agency request, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 9/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025?ref=fdaweb.com) says the specific deviations were:

- failure to demonstrate that the firm’s manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes; and
- failure to test the identity of each batch of incoming production material.

The letter notes that FDA placed all drugs and drug products offered for import into the U.S. on a 7/9 Import Alert. Chengdu was told to correct the deviations promptly and to respond with a list of specific actions it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.