FDA EIR - Huzhou Zhanwang Pharmaceutical Co., Ltd. - March 29, 2024

An FDA Current Good Manufacturing Practice (CGMP) inspection of Huzhou Zhanwang Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) manufacturer, was conducted from March 25 to March 29, 2024. This unannounced inspection, performed under Compliance Program CP7356.002F, covered non-sterile API products and all six drug systems: Quality, Production, Laboratory Control, Materials, Facilities and Equipment, and Packaging and Labeling. While no FDA Form-483 was issued, the inspection revealed three verbal observations. These included issues with facility and equipment cleanliness, such as residue in cleaned production tanks, dead insects in the dryer and other areas, inconsistent coverage of discharge ports, and an ongoing leak near a tank. Additionally, gaps were identified in the tracking of materials, samples, and finished products; for instance, raw material logbooks lacked specific location details, and microbiology lab sample movements were not logged. Despite these findings, the firm was responsive and initiated several Corrective and Preventive Actions (CAPAs) during the inspection to address the identified concerns. Consequently, the inspection was classified as "No Action Indicated" (NAI), signifying that no further regulatory action by the FDA is required at this time.