FDA 483 - Adimmune Corporation - November 21, 2023

The FDA conducted an inspection of Adimmune Corporation, a biological drug manufacturer located in Taichung City, Taiwan, from November 13 to November 21, 2023. The inspection revealed significant compliance issues related to documentation and equipment control. Key observations included the lack of comprehensive batch records, which failed to document critical production instructions and data. Specifically, there were no data logs for differential pressure alarms during batch production, and batch records did not identify equipment used in filling operations or document parameters of the filling machines.

Additionally, the inspection highlighted inadequate control over automatic equipment used for visual inspection of vaccine products. The automated visual inspection system had duplicate recipe files with different parameters, potentially leading to confusion and inconsistent quality control during commercial batch production.

These observations were made under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which mandates the documentation of conditions that may lead to contamination or health hazards. Adimmune Corporation is required to address these deficiencies by implementing corrective actions to ensure compliance with FDA regulations. The company is encouraged to discuss objections or corrective measures with FDA representatives or submit information to the FDA for further review.