苑东生物(688513.SH)：全资子公司硕德药业通过美国FDA现场检查

Core Viewpoint - Yuan Dong Biotech (688513.SH) announced that its subsidiary, Shuo De Pharmaceutical, received two on-site inspection reports from the US FDA, passing with zero deficiencies, which indicates compliance with FDA standards and supports the acceleration of its ANDA product approval process in the US [1] Group 1 - Shuo De Pharmaceutical successfully passed its second FDA on-site inspection, marking the first inspection of its nasal spray production line [1] - The inspected product is Naloxone Hydrochloride Nasal Spray, with FDA FEI number 3018360274 [1] - The successful inspection reflects the company's adherence to production management quality systems and regulatory compliance, facilitating the implementation of its internationalization strategy [1]