483
Englewood Lab Korea Co., Ltd.Englewood Lab Korea Co., Ltd. – FDA 483, Oct 25, 2024
Record Details
An FDA inspection of Englewood Lab Korea Co., Ltd., an OTC pharmaceutical manufacturer, revealed three significant observations. These included deficiencies in microbiological testing of components, failure to fully follow quality control unit procedures, and inadequate recording and justification of deviations from production and process control procedures, specifically regarding actions to prevent reoccurrence.
View Company Profile
ID · 6a134621-bb4b-4ce8-82d1-ddff864c603a
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.