From June 1 to 5, United Laboratories (Inner Mongolia) Co., Ltd. successfully completed two major international regulatory inspections simultaneously: the German BJV EU-GMP re-inspection and the U.S. FDA unannounced inspection. With a dedicated inspection team handling both assessments in parallel, the company successfully met the stringent requirements of both regulatory authorities, demonstrating the strength of its mature and comprehensive international quality management system, which gained recognition from two globally authoritative regulatory bodies.

The simultaneous dual inspections presented significantly greater challenges than a conventional single inspection, as the EU and U.S. regulatory frameworks operate under independent standards with different focuses and evaluation criteria. From June 1 to 3, German BJV inspectors conducted an EU-GMP re-inspection covering amoxicillin and ampicillin APIs, as well as the key starting material 6-APA. The inspection comprehensively assessed multiple areas, including production facilities, equipment maintenance and operations, quality control, and material storage management.

From June 1 to 5, U.S. FDA inspection experts conducted an unannounced on-site inspection at United Laboratories (Inner Mongolia) Co., Ltd., carrying out a comprehensive review of the 6-APA product. The inspection covered a wide range of areas, including production management, packaging and labeling, qualification and validation, process controls, stability studies, product release, electronic raw data management, OOS investigations, deviation investigations, change controls, complaints, corrective and preventive actions (CAPA), and full traceability throughout the sales batch lifecycle. The inspection team conducted a rigorous assessment of key compliance areas, including employees’ operational capabilities, familiarity with personnel qualifications, the effectiveness of root cause investigations and corrective actions for abnormal events, as well as equipment and facility maintenance management.

This FDA unannounced inspection featured characteristics of unpredictability, randomness, and in-depth verification. The inspection involved a broad scope of documentation, requiring the retrieval of six years’ worth of comprehensive original records, covering production processes, cleaning procedures, analytical method validation, equipment qualification, instrument calibration, deviations, change controls, OOS investigations, CAPA, and corresponding review checklists, files, supporting records, and documentation. The review even included historical materials such as the initial validation documents from 2013, with most documents requiring complete translated versions. Facing multiple challenges, including a tight timeline, stringent standards, extensive documentation requirements, and simultaneous dual inspections, United Laboratories (Inner Mongolia) established a dedicated quality inspection task force that worked around the clock. During the day, the team supported on-site inquiries and inspections; at night, they organized, translated, and reviewed extensive documentation while continuously improving the quality management system materials. The senior management team of United Laboratories (Inner Mongolia) coordinated overall planning, refined responsibilities, and closely supervised execution. All production units and functional departments worked collaboratively to ensure standardized on-site management, accurate document provision, and professional responses to inspectors’ inquiries. Through strong professional capabilities and resilience under pressure, United Laboratories employees successfully navigated the intensive inspection process, demonstrating a high level of professionalism and dedication.

Following the completion of the inspections, Mr.Zhang, General Manager of United Laboratories (Inner Mongolia), expressed his appreciation to the inspection experts from both regulatory authorities and stated that the company would carefully review each inspection observation and continue to optimize its end-to-end quality management system. During the on-site inspections, the stability and compliance of the company’s quality system operations received high recognition from regulatory experts from both the European Union and the United States. The FDA inspection team specifically acknowledged that the quality management system of United Laboratories (Inner Mongolia) is robust, effective, and well-established.

The two on-site inspections have now been successfully completed, with the company awaiting the final official conclusions. The successful completion of this dual-track inspection demonstrates the strong quality capabilities and team cohesion of United Laboratories (Inner Mongolia). Moving forward, United Laboratories will take this inspection as a new starting point, continue to uphold global pharmaceutical compliance standards, deepen its international development strategy, and strengthen its global presence by delivering high-quality API products and building a stronger international brand for Chinese pharmaceuticals.