483
Lexenpharm (Suzhou) LimitedLexenpharm (Suzhou) Limited – FDA 483, Sep 4, 2025
Record Details
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.
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ID · d6565661-53d5-4b5b-8dde-780300a49937
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