FDA 483 - Sichuan Qingmu Pharmaceutical Co., Ltd - September 07, 2021
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 Sichuan Qingmu Pharmaceutical Co., Ltd, an Active Pharmaceutical Ingredient Manufacturer, revealed significant deficiencies in quality unit procedures. The firm failed to perform required performance qualifications for critical manufacturing equipment and improperly classified a critical equipment change as minor. Additionally, the inspection found inadequate written records for investigations into batch failures, specifically concerning discrepancies in Thin Layer Chromatography (TLC) results and missing raw data.
ID · ad07a28c-e35c-4fa4-ab3b-8609bf1e66c5