483
Livzon Group (Ningxia) Pharmaceutical Co., Ltd.Livzon Group (Ningxia) Pharmaceutical Co., Ltd. – FDA 483, Oct 19, 2018
Record Details
The FDA inspected Livzon Group (Ningxia) Pharmaceutical Co., Ltd., an API and intermediate manufacturer, and found significant deficiencies across multiple areas. These included inadequate equipment cleaning, poor warehousing controls, facilities in disrepair, and insufficient labeling procedures. The inspection also revealed issues with stability studies, inventory records, environmental monitoring, OOS investigations, laboratory controls, batch record documentation, and shipping records.
- Inspection date
- October 19, 2018
- Product type
- drugs
View Company Profile
ID · ca2b5e84-c11a-4060-af74-e395a6c584ed
Other documents for Livzon Group (Ningxia) Pharmaceutical Co., Ltd.
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.