FDA 483 - CSL Plasma Inc. - December 16, 2016

An FDA inspection at CSL Plasma, Inc.'s plasmapheresis center in Baltimore, Maryland, from December 14-16, 2016, resulted in an FDA Form 483 with two main observations. The first issue concerned donor notification: the firm did not consistently make reasonable attempts to inform deferred donors of positive test results for transfusion-transmitted infections like syphilis, HBsAg, and Anti-HCV. Despite initial contact, follow-up efforts were often not documented when donors failed to return for confirmatory tests or counseling, contrary to the company's standard operating procedures. Some cases were reportedly closed by Quality Assurance without complete resolution. The second observation highlighted failures in donor eligibility screening. Employees did not consistently conduct thorough physical examinations of donor arms and forearms during pre-donation assessments for signs of infection, inflammation, lesions, or indications of drug injection. Records sometimes marked examinations as "Acceptable" even when proper inspections were not performed, violating internal protocols for donor suitability. CSL Plasma, Inc. is expected to address these observations by implementing corrective actions to ensure compliance with regulatory standards for donor notification and comprehensive pre-donation assessments.