FDA 483 - TF Health Corp. - May 06, 2022

An FDA inspection of TF Health Corp. DBA Breezing Co., a medical device manufacturer in Tempe, AZ, revealed two significant observations. The firm failed to document the evaluation of potential suppliers, contractors, and consultants as required by their own SOPs. Additionally, rework and reevaluation activities for out-of-range sensor parameters were not documented in the device history record.