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

Source: https://www.globalkeysolutions.net/records/483/tf-health-corp/73225bf7-cdab-46a5-8a65-e539a17cf17e

> FDA 483 for TF Health Corp. on May 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TF Health Corp.
- Inspection Date: 2022-05-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/tf-health-corp/02ce2fc4-b120-43d2-948b-913959945bd5

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6