# FDA 483 - Healthlight LLC - February 26, 2018

Source: https://www.globalkeysolutions.net/records/483/healthlight-llc/e56c7c7b-ecb5-4ac9-ad37-44de538438e7

> FDA 483 for Healthlight LLC on February 26, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Healthlight LLC
- Inspection Date: 2018-02-26
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Healthlight LLC, a medical device manufacturer in Schaumburg, IL, revealed significant deficiencies in their quality system. The firm failed to adequately establish corrective and preventive action (CAPA) procedures and did not properly maintain device history records. These issues indicate a lack of robust controls over product quality and documentation practices.

## Related Documents

- [483 - 2021-03-11](https://www.globalkeysolutions.net/records/483/healthlight-llc/8efde598-1450-43a8-9577-60b4ce211346)

## Related Officers

- [Recall Coordinator](https://www.globalkeysolutions.net/people/emma-schaefer/10299982-dce6-4fea-a3e9-8167030b0331)

Company: https://www.globalkeysolutions.net/companies/healthlight-llc/b33ebb64-ee6d-4ca5-a39a-1ad84a442973

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