# FDA 483 - Microlight Corporation of America - July 11, 2018

Source: https://www.globalkeysolutions.net/records/483/microlight-corporation-of-america/9d3e3827-7be1-494b-9423-ff13ae1de46a

> FDA 483 for Microlight Corporation of America on July 11, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microlight Corporation of America
- Inspection Date: 2018-07-11
- Product Type: device
- Office Name: Dallas District Office
- Summary: Microlight Corporation of America in Sugar Land, TX, was cited for significant quality system deficiencies related to its Class IIb/IIIb laser medical devices. The firm failed to maintain device master records, adequately investigate device complaints, establish proper servicing procedures, and provide requested records to the FDA. Additionally, there was a lack of electronic product radiation control test records for components.

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## Related Officers

- [Jocelyn C. Turner](https://www.globalkeysolutions.net/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.globalkeysolutions.net/companies/microlight-corporation-of-america/836a7125-9dee-4835-9b1f-86b8ccc5ac45

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9