FDA EIR - Octapharma Plasma, Inc. - October 24, 2019

An FDA inspection of Octapharma Plasma, Inc. in Orlando, FL, was conducted from October 22-24, 2019. This comprehensive review assessed the Source Plasma facility's adherence to applicable federal laws and regulations for blood and blood products, primarily under the Public Health Services Act and the Federal Food, Drug, and Cosmetic Act. The inspection resulted in the issuance of an FDA Form 483 due to the company not consistently following its written standard operating procedures (SOPs) for blood collection. Specifically, an employee was observed performing venipuncture with inadequate scrub time for the site and palpating the vein after arm preparation but before needle insertion, which contradicted the firm's established SOPs. Additional issues discussed, though not on the 483, included an employee improperly assisting a donor with a health questionnaire, insufficient detail in some investigative records, and a recurring observation from a previous inspection regarding the lack of a system to notify cohabitants of reactive donors who fail to return for counseling. The Center Director, Dayuna E. Dixon, confirmed immediate corrective action for the 483 observation and committed to submitting a written response to the FDA's Florida District Office within 15 business days, addressing all identified concerns.