FDA 483 - Analytical Solutions - November 28, 2025

An FDA inspection conducted at Analytical Solutions, a contract testing laboratory, from November 26-28, 2025, identified several significant quality control deficiencies, resulting in an FDA Form 483. The inspection revealed that the quality control unit lacked adequate authority and oversight, particularly concerning Uninterrupted Power Supply (UPS) systems in the laboratory. The firm had no control procedures for UPS monitoring or preventive maintenance, nor clear guidelines for battery health checks and replacement. Investigations into power outages were also found deficient, with discrepancies in closure statuses and a lack of proper verification. A repeat deficiency was cited for the firm's failure to thoroughly investigate unexplained discrepancies and out-of-specification results. One instance involved an Out-of-Specification (OOS) investigation where a drug product batch failing specifications was released after continued testing yielded conforming results, despite the initial OOS being confirmed. Additionally, several change controls and laboratory incident investigations remained open for extended periods without proper justification or approval for extensions. Furthermore, the inspection noted deficiencies in determining conformance to written specifications for drug products. A substantial backlog of approximately 80 samples, including critical stability samples, had been received but not registered for testing, some for months or even years. The firm's sample handling procedures lacked defined timelines for registration, testing, and reporting results to customers. These observations indicate non-compliance with fundamental quality system requirements expected under FDA regulations for contract testing laboratories. Analytical Solutions is required to submit a comprehensive response outlining corrective and preventive actions to rectify these issues and ensure robust quality control and timely investigation processes.