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

An FDA inspection of Advanced Botanical Consulting & Testing Inc. dba ABC Testing, a contract testing laboratory in Tustin, CA, was conducted from November 1 to November 13, 2018. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, identified several critical deficiencies in the company's quality systems. Key issues included the failure to verify the suitability of testing methods, such as not determining system suitability for drug product analyses and lacking method suitability for microbial testing. Laboratory records were incomplete, notably missing lot numbers and expiration dates for analytical standards.

Significant concerns were also raised regarding inadequate controls over computer systems. The quality unit failed to review audit trails, and some systems lacked proper audit trail functionality or activation. There was no system to protect raw electronic data from deletion or overwriting, nor were personal user logins and passwords in place to restrict access. Additionally, the firm lacked a formal change control system for facility or method modifications. Equipment management was deficient, with no procedures for stability chamber monitoring, inadequate actions for out-of-tolerance balances, and unvalidated spreadsheet calculations. The company is expected to implement comprehensive corrective actions to resolve these observations and ensure regulatory compliance.