483
ARL Biopharma, Inc.ARL Biopharma, Inc. – FDA 483, Sep 5, 2019
Record Details
Alc Biopharma Inc., a contract testing laboratory in Oklahoma City, was cited for significant data integrity issues during an FDA inspection. The firm failed to implement proper controls for electronic laboratory equipment, including a lack of unique user access and an absence of audit trail features for HPLC software. These deficiencies raise concerns about the reliability and traceability of electronic raw data.
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- Dallas District Office
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ID · 4e19e914-ce9d-4342-96dc-f564f8420248
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