FDA 483 - ARL Biopharma, Inc. dba Analytical Research Laboratories - September 05, 2019

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.