FDA 483 - Jiangsu Hansoh Pharmaceutical Group Co., Ltd - June 13, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Jiangsu Hansoh Pharmaceutical Group Co. Ltd. in Lianyungang, China, a finished drug product manufacturer, revealed significant deficiencies in their production and process control systems. Observations included a lack of written procedures for assuring drug product quality, failure to follow established procedures, and inadequate validation of manufacturing processes. The firm also lacked appropriate sampling procedures for incoming components, indicating a broad failure in quality assurance.
ID · b4c214ad-3e91-4467-97b4-d9b4363be304