- Apeloa Pharmaceutical has successfully passed its 20th inspection by the U.S. Food and Drug Administration (FDA) with a No Action Indicated (NAI) result.
- The FDA inspection confirmed full compliance at the company’s Zhejiang Apeloa Tospo Pharmaceutical Co., Ltd. facility, with no Form 483 observations issued.
Apeloa Pharmaceutical, a global provider of technology-driven pharmaceutical manufacturing solutions, has achieved a major compliance milestone by passing its 20th inspection by the U.S. Food and Drug Administration (FDA).
The company’s subsidiary, Zhejiang Apeloa Tospo Pharmaceutical Co., Ltd., which provides manufacturing services for Raw Starting Materials (RSMs), Intermediates, and Active Pharmaceutical Ingredients (APIs), successfully completed the FDA’s current Good Manufacturing Practice (cGMP) surveillance inspection with a No Action Indicated (NAI) result on 24 October 2025.
The five-day routine inspection evaluated products and exports registered in the United States, assessing six key systems: quality, production, materials, equipment and facilities, packaging and labelling, and laboratory control. No objectionable conditions were identified, and the FDA issued no Form 483 observations.
According to the company, the FDA also recognised Apeloa’s performance in compliance management, process control, and data integrity. This successful audit marks the 20th time Apeloa has passed an FDA inspection.
