FDA EIR - Hybio Pharmaceutical Co. Ltd (Site 1) - June 26, 2015

The U.S. Food and Drug Administration conducted an initial Pre-Approval and Good Manufacturing Practice (GMP) inspection of Hybio Pharmaceutical Co. Ltd in Shenzhen, China, from June 22 to June 26, 2015. This assessment, performed under CDER's compliance programs for active pharmaceutical ingredients (APIs), aimed to evaluate the company's adherence to regulatory standards for products intended for the U.S. market. The inspection covered various systems, including Quality, Facilities and Equipment, Production, Materials, Packaging and Labeling, and Laboratory Control Systems.

The FDA identified four main objectionable conditions, documented on an FDA-483 form. These included inadequate laboratory controls for in-process materials, insufficient use of protective apparel to prevent product contamination, uncontrolled air recirculation in production areas, and deficient procedures for equipment cleaning and maintenance. Additional observations noted an outdated operating system for labeling software and concerns with analytical method validation.

Hybio Pharmaceutical Co. Ltd's management acknowledged these findings, committing to implement necessary corrective actions. Some of these actions were reportedly initiated and verified during the inspection. The company was required to submit a comprehensive written response to the FDA within 15 business days. As a result of the firm's commitment to address the issues, the inspection was classified as "Voluntary Action Indicated" (VAI), indicating that regulatory action was not deemed necessary at that time.