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

Source: https://www.keypedia.com/records/483/immucor-inc/19575f6c-defc-41ec-9e26-8fcd39e5dc80

> FDA 483 for Immucor, Inc. on July 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immucor, Inc.
- Inspection Date: 2021-07-30
- Product Type: device
- Office Name: Atlanta District Office
- Summary: 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.

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Company: https://www.keypedia.com/companies/immucor-inc/d0ef7e50-5786-49f6-8d03-5dc5af7f2739

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7