FDA 483 - Advanced Botanical Consulting & Testing, LLC - November 13, 2018

Advanced Botanical Consulting & Testing Inc dba ABC Testing, a contract testing laboratory in Tustin, CA, was cited for significant deficiencies in its laboratory operations. Observations included inadequate method suitability verification, incomplete laboratory records, insufficient computer system controls, and a lack of change control for laboratory mechanisms. Additionally, the firm failed to perform routine equipment calibration and validation according to written programs.