The U.S. Food and Drug Administration (FDA) has issued a warning letter to Sichuan Deebio Pharmaceutical Co., Ltd., a China-based active pharmaceutical ingredient (API) manufacturer, following an on-site inspection that revealed significant deviations from current Good Manufacturing Practice (cGMP) standards.
The FDA’s letter underscores Deebio’s shortcomings in properly documenting laboratory controls, alongside generally inadequate quality systems, documentation, and data integrity. The agency had previously issued a Form 483 in September 2023. Deebio is currently addressing these concerns, and the FDA has recommended that the company engage external consultants to develop a corrective action plan. A specific deadline for implementing the necessary changes has yet to be disclosed.- Flcube.com
