# FDA 483 - Exer Labs, Inc. - October 24, 2024

Source: https://www.globalkeysolutions.net/records/483/exer-labs-inc/8b78fe75-31b8-4c41-b537-3ac16bea5718

> FDA 483 for Exer Labs, Inc. on October 24, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Exer Labs, Inc.
- Inspection Date: 2024-10-24
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Exer Labs, Inc., a medical device manufacturer in Denver, CO, revealed 10 significant observations regarding their quality system. The firm lacked established and documented procedures across numerous critical areas, including design control, corrective and preventive actions, complaint handling, medical device reporting, and management review. These findings indicate a fundamental absence of a robust quality management system for their Exer Scan Software as a Medical Device (SaMD) product.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/exer-labs-inc/e1bf8869-a6ba-4794-b80e-05a59c515e96

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face