# FDA 483 - Lexenpharm (Suzhou) Limited - September 04, 2025

Source: https://www.keypedia.com/records/483/lexenpharm-suzhou-limited/d6565661-53d5-4b5b-8dde-780300a49937

> FDA 483 for Lexenpharm (Suzhou) Limited on September 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lexenpharm (Suzhou) Limited
- Inspection Date: 2025-09-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Lexenpharm (Suzhou) Limited, a sterile drug manufacturer, received an FDA Form 483 for significant deficiencies in laboratory record-keeping. Inspectors observed torn and discarded balance printouts and other GMP records in the QC laboratory, indicating a failure to maintain complete data and adhere to established documentation procedures. This raises concerns about data integrity and compliance with good manufacturing practices.

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.keypedia.com/companies/lexenpharm-suzhou-limited/7583aa85-4a9c-4db2-ad49-6d411885ad5f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8