# FDA 483 - Infinite Biomedical Technologies - June 10, 2022

Source: https://www.keypedia.com/records/483/infinite-biomedical-technologies/5cc2c093-724e-4f88-93cd-028071b2900b

> FDA 483 for Infinite Biomedical Technologies on June 10, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infinite Biomedical Technologies
- Inspection Date: 2022-06-10
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Infinite Biomedical Technologies in Baltimore, MD, revealed critical deficiencies in their quality system. The firm failed to submit Medical Device Reports for serious incidents involving their FlexCell battery device, including overheating, fire, and explosion. Additionally, the inspection identified inadequate corrective and preventive action procedures, unvalidated third-party software, and poorly defined supplier requirements, indicating a systemic lack of control over key quality processes.

## Related Officers

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

Company: https://www.keypedia.com/companies/infinite-biomedical-technologies/b51ba27d-611d-46a8-82ca-d09ef718e3bb

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64