FDA 483 - Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) - August 08, 2023

An FDA inspection of Hybio Pharmaceutical Co., Ltd.'s Pingshan Factory, a sterile drug manufacturer, revealed significant deficiencies in aseptic processing and equipment cleaning. Observations included inadequate sterility testing, poor aseptic techniques by operators, and improper storage of tools, leading to potential microbiological contamination. Additionally, the firm lacked specific written procedures for cleaning and sanitizing critical equipment components within the aseptic processing area.