FDA 483 - Infinite Biomedical Technologies - June 10, 2022

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.