FDA 483 - CSL Plasma Inc. - July 12, 2024

An FDA inspection conducted at CSL Plasma Inc.'s facility in Saginaw, MI, from July 8-12, 2024, revealed a significant observation regarding facility maintenance. The primary issue identified was the firm's failure to maintain its premises in a clean and orderly manner. Specifically, investigators observed extensive insect infestations across critical operational areas. On July 9, 2024, approximately 30 dead and alive beetles of various species were found in the packing/shipping room, the soft good supply storage room, and the miscellaneous/cleaning supply room, with about 15 captured in a glue trap. The following day, July 10, an additional 7 live and dead insects were noted in the packing/shipping room and on the donor floor. Furthermore, the inspection identified multiple air gaps between the building's exterior and interior, which likely contributed to the pest entry. These findings were reported as inspectional observations under Section 704(b) of the Federal Food, Drug and Cosmetic Act. While not a final determination of compliance, these observations indicate conditions that could lead to contamination. CSL Plasma Inc. is required to respond to these findings, either by discussing any objections with the FDA representative or by promptly implementing and documenting comprehensive corrective actions to address the identified sanitation and pest control deficiencies, ensuring compliance with regulatory standards.