# FDA 483 - Advanced Cooling Therapy Inc. - October 22, 2021

Source: https://www.keypedia.com/records/483/advanced-cooling-therapy-inc/0270c64e-0793-4804-8e28-97240569faf6

> FDA 483 for Advanced Cooling Therapy Inc. on October 22, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Advanced Cooling Therapy Inc.
- Inspection Date: 2021-10-22
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Advanced Cooling Therapy Inc. in Chicago, IL, identified four significant deficiencies in their quality system for medical devices. The firm failed to ensure device manufacturing aligned with master records, promptly investigate MDR reportable complaints, document corrective actions, and establish adequate finished device acceptance procedures. These issues indicate a lack of robust quality control for their EnsoETM device.

## Related Officers

- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.keypedia.com/companies/advanced-cooling-therapy-inc/4c5c3b18-07e0-448b-b0f4-d23f3916eab5

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669