# FDA 483 - BTE Technologies, LLC - January 31, 2020

Source: https://www.keypedia.com/records/483/bte-technologies-llc/d3121dd7-4b21-464f-9763-ed12753aaef9

> FDA 483 for BTE Technologies, LLC on January 31, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BTE Technologies, LLC
- Inspection Date: 2020-01-31
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: BTE Technologies, LLC, a medical device manufacturer in Hanover, MD, was inspected by the FDA, revealing two significant observations. The firm lacked adequately established procedures for design review, including proper planning, independent reviewers, and documentation. Additionally, procedures for controlling nonconforming products were found to be inadequate, specifically regarding justification for disposition and documented rework procedures.

## Related Officers

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

Company: https://www.keypedia.com/companies/bte-technologies-llc/3b006b03-6d4f-4386-a271-21f12b3d0515

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