# FDA 483 - Healthlight LLC - March 11, 2021

Source: https://www.globalkeysolutions.net/records/483/healthlight-llc/8efde598-1450-43a8-9577-60b4ce211346

> FDA 483 for Healthlight LLC on March 11, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Healthlight LLC
- Inspection Date: 2021-03-11
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Healthlight LLC, a medical device manufacturer in Schaumburg, IL, revealed a significant deficiency related to their quality system. The firm was cited for failing to establish written procedures for Medical Device Reporting (MDR). This indicates a fundamental gap in their regulatory compliance for post-market surveillance.

## Related Documents

- [483 - 2018-02-26](https://www.globalkeysolutions.net/records/483/healthlight-llc/e56c7c7b-ecb5-4ac9-ad37-44de538438e7)

## Related Officers

- [Nicholas Z. Lu](https://www.globalkeysolutions.net/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

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