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

Source: https://www.keypedia.com/records/483/boehringer-ingelheim-biopharmaceuticals-china-ltd/043bec50-de87-4e6d-a9d9-e057770f067b

> FDA 483 for Boehringer Ingelheim Biopharmaceuticals (China) Ltd. on June 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Biopharmaceuticals (China) Ltd.
- Inspection Date: 2023-06-09
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Yiwei Li, Ph.D., Supervisory Chemist](https://www.keypedia.com/people/yiwei-li-phd-supervisory-chemist/25391f15-b3ee-400e-9e10-4fc2b674facc)
- [Leiyun Boone, PhD, Lead Biologist](https://www.keypedia.com/people/leiyun-boone-phd-lead-biologist/bff36082-6e40-4d97-b452-8b89d415e5be)
- [Zhong Li, Ph.D., Sr. Pharmaceutical Quality Assessor](https://www.keypedia.com/people/zhong-li-phd-sr-pharmaceutical-quality-assessor/cdc177bb-92f6-4d53-ba84-6e878c68917a)

Company: https://www.keypedia.com/companies/boehringer-ingelheim-biopharmaceuticals-china-ltd/be450a8b-4f71-4f06-96b3-908a2ed1b580

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd