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

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.