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# API Manufacturing Deviations at Sichuan Deebio
- URL: https://www.fdaweb.com/api-manufacturing-deviations-at-sichuan-deebio/
- Published: 2024-02-20T12:00:00.000Z
- Updated: 2026-09-14T14:23:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156386

A 9/4-9/8/2023 FDA inspection at Sichuan Deebio Pharmaceutical Co. Ltd., in Sichuan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 2/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sichuan-deebio-pharmaceutical-co-ltd-669808-02142024?ref=fdaweb.com) says specific deviations were:

- failing to follow and document laboratory controls at the time of performance, and failing to document and explain any departures from laboratory procedures; and
- failure of the company quality unit to exercise its responsibility to ensure the API and intermediates manufactured at the facility comply with CGMP.

The letter says the firm’s quality systems are inadequate and don’t ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured. It recommends Sichuan retain a qualified consultant to assist it in meeting CGMP requirements.

FDA acknowledges the firm’s commitment to suspend production of a redacted API for the U.S. market and asks it to clarify whether it intends to resume manufacturing drugs for the U.S. market at the facility in the future.

Sichuan 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.