# FDA 483 - Tetracore, Inc. - December 06, 2019

Source: https://www.keypedia.com/records/483/tetracore-inc/39ecd2de-14f0-42e3-afca-054bbf3d9d52

> FDA 483 for Tetracore, Inc. on December 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tetracore, Inc.
- Inspection Date: 2019-12-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Tetracore, Inc. in Rockville, MD, a medical device manufacturer, was inspected by the FDA from December 3-6, 2019. The inspection revealed significant deficiencies in their quality system, including a lack of management review, inadequate equipment installation, absence of risk analysis, and poorly established procedures for corrective and preventive actions and quality audits. These findings indicate a systemic failure to maintain an effective quality system.

## Related Officers

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

Company: https://www.keypedia.com/companies/tetracore-inc/f7bc78b5-c7b9-4c9c-9220-893497f82627

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