FDA EIR - Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). - July 20, 2023

An FDA surveillance inspection was conducted at Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API), located in Xianju, China, from July 17 to July 20, 2023. This inspection focused on the firm's manufacturing of Active Pharmaceutical Ingredients (APIs) and intermediates for both human and animal drugs, adhering to the Q7 Good Manufacturing Practice Guide for APIs and relevant compliance programs 7356.002F and others for human and animal drug evaluation. The comprehensive assessment covered the company's Quality, Production, and Laboratory Systems, along with its readiness for commercial manufacturing, conformance to applications, data integrity, and commitment to quality. Significantly, no FDA Form 483 (Inspectional Observations) was issued at the conclusion of this inspection, indicating a high level of compliance. During the inspection, a minor verbal observation regarding the absence of soap at a handwashing station was promptly addressed and corrected by the firm's management. Furthermore, issues identified during a previous inspection in August 2019, which concerned the review of audit trails for release testing instruments, were confirmed as rectified. Given the findings, the inspection was classified as 'No Action Indicated' (NAI), signifying that no further regulatory actions are required by the FDA. The company demonstrated overall compliance with the regulatory standards during this review.