FDA EIR - ACTA Laboratories, Inc. - January 19, 2018

An FDA inspection of ACTA Laboratories, Inc., a contract test laboratory, was conducted from January 16-19, 2018, focusing on operations related to an Abbreviated New Drug Application (ANDA). The inspection, performed under the FD&C Act and cGMP regulations, identified several critical issues and resulted in the issuance of a 3-item FDA Form 483. The main violations included the firm's failure to verify the suitability of various testing methods, such as assays for active pharmaceutical ingredients and particulate matter tests, under actual conditions of use. Significant concerns were also noted regarding inadequate controls over computerized systems, as both authorized administrators and even a lab technician could access and delete critical raw HPLC data and backup files. Furthermore, the laboratory lacked written records for investigating unexplained discrepancies, specifically stability chamber alarm events and temperature excursions, which could impact sample integrity. Verbal observations also highlighted that forced degradation evaluation was conducted before method verification for impurity assays was complete, standard test procedures were not established for USP-based methods, and there was no evidence to support the standard one-year expiration date assigned to chemical reference standards. ACTA Laboratories management acknowledged the observations, stating they would submit a written response to the FDA within 15 business days, and committed to implementing corrective actions including immediate fixes to computer system access controls, establishing an alarm log and investigation system for stability chambers, and developing standard testing procedures.