# FDA 483 - Exercore, LLC - December 18, 2018

Source: https://www.keypedia.com/records/483/exercore-llc/6fba199a-9503-428a-b15c-04a989f5adba

> FDA 483 for Exercore, LLC on December 18, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exercore, LLC
- Inspection Date: 2018-12-18
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Exercore, LLC in Shakopee, MN, revealed significant deficiencies in the firm's quality system for its eustachian tube exerciser. The inspection found a pervasive lack of established procedures across critical areas including design control, corrective and preventive actions, complaint handling, medical device reporting, non-conforming product control, and purchasing controls. These findings indicate a fundamental absence of a robust quality management system.

## Related Documents

- [483 - 2021-09-02](https://www.keypedia.com/records/483/exercore-llc/767168d2-54a9-4b5e-a669-2b807b2dbd5d)

## Related Officers

- [investigator](https://www.keypedia.com/people/jennifer-s-ness/532f8a81-e393-4e83-b5f2-a72362e966de)

Company: https://www.keypedia.com/companies/exercore-llc/ec79efa9-67bc-4138-ad58-1da076398e9b

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d