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

An FDA inspection of Advanced Botanical Consulting & Testing Inc. (dba ABC Testing) in Tustin, CA, conducted from March 12-16, 2012, revealed significant compliance failures. This initial inspection, part of a pre-approval assessment for an Abbreviated New Drug Application (ANDA) involving drug component testing, resulted in an FDA-483 citing nine observations under the Current Good Manufacturing Practice (CGMP) regulations (21 CFR).

Major violations included inadequate verification of compendial test methods and a complete absence of validation for non-compendial methods, critically affecting the reliability of drug component analysis. The firm failed to perform essential system suitability checks before sample analysis, and laboratory records were consistently incomplete, lacking vital details such as reagent lot numbers, equipment parameters, and identification. A fundamental breakdown in quality control was evident as laboratory notebooks were not reviewed by a second individual for accuracy or completeness.

Further issues involved severe data integrity concerns: the gas chromatograph software lacked audit trails and proper user access controls, making raw data vulnerable to unauthorized changes or deletion. There was no documented program for equipment qualification, preventive maintenance, or a robust change control system for methods and instrumentation. The quality system also lacked a finalized procedure for Out-of-Specification investigations. ABC Testing, reportedly unaware of GMP requirements for drug product testing, is now required to address these deficiencies to ensure compliance with pharmaceutical regulatory standards.