# FDA 483 - Diacor, Inc - October 03, 2019

Source: https://www.keypedia.com/records/483/diacor-inc/58a0b546-a219-4588-9373-cae5bedd181c

> FDA 483 for Diacor, Inc on October 03, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diacor, Inc
- Inspection Date: 2019-10-03
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Elecsys, Inc. in West Valley City, UT, a medical device manufacturer, revealed two significant observations. The firm failed to adequately establish procedures for design changes, a repeat observation from a previous inspection, and did not properly maintain device history records for its Zephyr XL Hoverboard device, showing out-of-range weight measurements. These findings indicate deficiencies in the firm's quality system and record-keeping practices.

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/diacor-inc/11688ab9-29f4-4edd-9d07-82c11bec238a

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