FDA EIR - Hybio Pharmaceutical Co. Ltd (Site 1) - March 30, 2018

An FDA inspection of Hybio Pharmaceutical Co. Ltd, located in Shenzhen, China, was conducted from March 26-30, 2018. This comprehensive inspection, part of an FDA drug surveillance program, focused on the company's manufacturing of non-sterile active pharmaceutical ingredients (APIs). The regulatory framework included Compliance Program 7356.002F for Bulk Pharmaceutical Chemicals and ICH Q7 Good Manufacturing Practice Guidance for APIs. The inspection identified several issues, leading to an FDA-483 observation document. Primary violations included the company's failure to verify that the specified 2-8°C storage conditions for starting material labels were maintained during transportation. Additionally, batch records were found to be incomplete, lacking details on transferred bucket usage and full label specimens. The labeling of shipped APIs also omitted necessary caution statements. While a previous inspection in 2015 had resulted in similar observations, the current inspection confirmed that corrections to those earlier issues had been made. For the recent findings, Hybio Pharmaceutical Co. Ltd management committed to addressing the observations and submitting a written response within 15 days. The inspection was categorized as "Voluntary Action Indicated" (VAI), signifying that while observations were made, the firm voluntarily agreed to take corrective actions without immediate regulatory enforcement.