483
Samsung Biologics Co., Ltd.FDA 483 - Samsung Biologics Co., Ltd. - March 14, 2018
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.
Record Details
An FDA inspection of Samsung Biologics in Incheon, Republic of Korea, identified significant deficiencies in quality assurance oversight and pest control. The firm lacked adequate risk assessment for drug substance intermediates, improperly stored micro testing media, and inadvertently discarded critical bioburden samples. Additionally, the pest control program was deemed inadequate due to variable alert and action limits.
Open in Dashboard
ID · ce260ba9-5da0-4986-9b6e-3fee4fc334d5