FDA 483 - Immucor, Inc. - July 30, 2021

Immucor, Inc., a medical device (IVD) manufacturer in Norcross, GA, was cited for six observations during an FDA inspection. The inspection revealed deficiencies in quality checks for in vitro diagnostic products, ineffective corrective and preventive actions for false negative test results, and inadequate investigations for out-of-specification results. Additionally, issues were noted with device history record maintenance, packaging and labeling operations failing to detect missing components, and insufficient equipment verification procedures.