FDA 483 - Octapharma Plasma, Inc. - March 07, 2023

An FDA inspection of Octapharma Plasma, Inc. in Houston, TX, revealed significant issues in their donor testing and notification processes. The firm failed to consistently provide correct test results for relevant transfusion-transmitted infections (RTTI) to deferred donors, including HIV and RPR results. Additionally, the company did not adhere to its own Standard Operating Procedure for donor notification and counseling documentation, making it impossible to verify what information was provided to donors.