FDA 483 - Immucor, Inc. - February 20, 2025

Immucor, Inc., a medical device manufacturer in Norcross, Georgia, underwent an FDA inspection from February 10 to February 20, 2025. The resulting Form 483 details seven significant observations concerning the facility's quality management and contamination control systems. Investigators identified apparent biological growth on several HEPA filters in production areas, some of which had not been replaced since 2009. This lack of maintenance coincided with thousands of consumer complaints regarding reagent red blood cells, including reports of bacterial contamination and incorrect test results.

Furthermore, the firm failed to establish adequate procedures for Corrective and Preventive Actions (CAPA). Specifically, Immucor did not thoroughly investigate the root causes of microbiological contamination or assess the risk to other product batches. The FDA also noted deficiencies in risk analysis, particularly regarding the use of products on unvalidated testing platforms and the potential for false-negative results that could lead to life-threatening medical errors. Additional issues included inadequate tracking of product rejection rates, failure to follow internal investigation timelines, and missing justifications for not reporting certain field actions to the agency.

These observations were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While the firm has promised to correct most of these issues and verified the correction of one reporting violation during the inspection, they are required to implement robust quality controls. Necessary actions include updating maintenance schedules, formalizing complaint investigations, and ensuring all potential medical device reports are properly assessed and submitted to regulatory authorities.