FDA 483 - KEDPlasma, LLC - November 10, 2022

An FDA inspection of KEDPlasma, LLC in Pensacola, FL, conducted from November 7-10, 2022, identified significant deficiencies at their Source Plasma Establishment. The inspection, carried out under the Federal Food, Drug and Cosmetic Act, highlighted two primary observations requiring attention.

First, the company failed to perform thorough investigations and maintain adequate records for unexplained discrepancies, specifically related to Corrective and Preventative Actions (CAPAs). Between 2020 and 2022, at least twelve major deviations lacked proper root cause analysis or effective evaluation of CAPAs, leading to recurring issues. This indicated a non-adherence to KEDPlasma's own "Donor Center Deviation Management Procedure" regarding investigation scope, assignment of responsibility, and target date adherence.

Second, employees did not consistently follow established written standard operating procedures for the collection of blood and blood components. Specific instances included inadequate venipuncture site preparation, such as insufficient scrub times or premature timer initiation by two employees. Furthermore, three employees demonstrated non-aseptic technique during donor disconnection by handling sterile gauze with their gloves before placing it on the venipuncture site. KEDPlasma, LLC is expected to address these observations promptly to ensure compliance with regulatory standards and internal procedures, thereby protecting product quality and donor safety.