Boehringer Ingelheim Biopharmaceuticals (China) Ltd.June 9, 2023

FDA 483 - Boehringer Ingelheim Biopharmaceuticals (China) Ltd. - June 09, 2023

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Record Details

An FDA inspection of Boehringer Ingelheim BioPharmaceuticals (China) Ltd. in Shanghai revealed significant deficiencies across multiple areas of drug substance and drug product manufacturing. Observations included failures in quality unit procedures, visual inspection processes, aseptic manufacturing controls, and data integrity. These issues indicate a lack of adherence to established protocols and inadequate controls, posing potential risks to product quality and sterility.

Company: Boehringer Ingelheim Biopharmaceuticals (China) Ltd.
Inspection Date: June 9, 2023
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Leiyun W. Boone (Lead Biologist)
Yiwei Li
Zhong Li

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ID · 043bec50-de87-4e6d-a9d9-e057770f067b