483
TF Health Corp.TF Health Corp. – FDA 483, May 6, 2022
Record Details
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.
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ID · 73225bf7-cdab-46a5-8a65-e539a17cf17e
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