FDA 483 - Pharmaron (Beijing) TSP Services Limited - August 01, 2025

Pharmaron (Beijing) TSP Services Limited received an FDA Form 483 following an inspection conducted from July 28 to August 1, 2025. The inspection identified significant deficiencies related to Good Laboratory Practice (GLP) regulations, specifically concerning the integrity of study data, archiving procedures, facility maintenance, and operational controls. Key observations included the study director's failure to ensure accurate data recording and verification, with instances such as incorrect test article storage details in final reports and unaddressed protocol deviations. Archiving practices were found lacking, with electronic data and critical correspondence not being transferred to archives promptly or completely, and index inaccuracies preventing expedient retrieval of records. Furthermore, the facility exhibited inadequate storage conditions for equipment and supplies, including items exposed to outdoor elements or stored in unsanitary environments. Deviations from standard operating procedures, such as the discontinuation of biweekly cage rotations without an updated SOP, were noted. Animal caging and equipment were not consistently cleaned or sanitized, with evidence of residue on "cleaned" items. Structural issues, including missing tiles, pitted floors, and water damage, indicated that the facility's construction was not suitable for proper nonclinical studies. The company is required to review these observations and implement comprehensive corrective actions to address the identified deficiencies and ensure full compliance with GLP standards.