FDA 483 - Advanced Botanical Consulting & Testing, LLC - March 16, 2012

Advanced Botanical Consulting & Testing Inc. (dba ABC Testing), a contract testing laboratory, received an FDA Form 483 following an inspection from March 12 to March 16, 2012. The inspection identified significant deficiencies primarily related to laboratory control systems and the quality unit, indicating non-compliance with Good Manufacturing Practices (GMP) for pharmaceutical testing. Key observations included the failure to verify the suitability of testing methods, such as the OVI2.M method for residual solvents, which lacked proper protocols, acceptance criteria, and system suitability. The firm also did not validate the non-compendial OVIFast.M method for residual solvent analysis. Further issues involved the absence of scientifically sound test procedures, incomplete laboratory records lacking essential data like standard lot numbers and equipment parameters, and a lack of second-person review for laboratory notebooks. Critical findings also highlighted inadequate controls over computer systems, specifically the absence of an audit trail for gas chromatograph software and no system to protect electronic raw data from deletion. The company failed to perform routine qualification and re-qualification of analytical equipment and lacked an established change control system for method modifications or equipment additions. Additionally, the quality control unit's responsibilities were not fully documented, with no approved Standard Operating Procedure for Out-of-Specification investigations. ABC Testing is required to implement comprehensive corrective actions to address these systemic issues, ensuring all testing methods are validated, laboratory records are complete and reviewed, data integrity is maintained, and quality system procedures are established and followed.