483
CSL Plasma Inc.FDA 483 - CSL Plasma Inc. - December 01, 2025
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
CSL Plasma Inc. in District Heights, MD, received a Form 483 with two observations during an inspection. The firm failed to prevent the release of unsuitable Source Plasma units for further manufacturing from donors with unconfirmed failed test results. Additionally, the company did not adequately notify donors of positive test results for transfusion-transmitted infections, including HIV, HCV, and HBV.
- Person
Open in Dashboard
ID · a631303f-fb3b-45fa-a2de-017990f73d5c