# FDA 483 - Life Technologies Corporation - June 14, 2021

Source: https://www.keypedia.com/records/483/life-technologies-corporation/83b40626-63d9-4252-bb67-c7f97ff1807a

> FDA 483 for Life Technologies Corporation on June 14, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Life Technologies Corporation
- Inspection Date: 2021-06-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Life Technologies Corporation in Frederick, MD, a medical device manufacturer, was cited for deficiencies during an FDA inspection. The firm's corrective and preventive action (CAPA) procedures were found to be inadequate, failing to consistently require full CAPA activities and ensure timely record closure. Additionally, the company distributed Oncomine Dx Target Test Devices with incorrect expiration dates and/or lot numbers on labeling due to various internal errors.

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/life-technologies-corporation/ab22940c-e27b-49ae-aa30-b01b7b45a5a7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e