# FDA 483 - Sharplight Technologies - February 14, 2019

Source: https://www.globalkeysolutions.net/records/483/sharplight-technologies/8fe6f9fc-6edb-4169-a07f-c95703f02ef7

> FDA 483 for Sharplight Technologies on February 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sharplight Technologies
- Inspection Date: 2019-02-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of SharpLight Technologies, a medical device firm in Rishon le-Tsiyon, Israel, revealed significant quality system deficiencies. The firm failed to adequately establish corrective and preventive action procedures and did not properly document design review results. Additionally, SharpLight Technologies introduced several class 2 medical/class IV laser devices into U.S. commerce without submitting required product reports and annual reports to the FDA.

## Related Documents

- [WARNING_LETTER - 2013-06-13](https://www.globalkeysolutions.net/records/warning_letter/sharplight-technologies/e348e9ca-7bd5-4834-b146-7e19942bead9)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)
- [investigator](https://www.globalkeysolutions.net/people/marissa-steinhagen/e7b201f4-63ce-4115-b412-714a0b8c25dc)

Company: https://www.globalkeysolutions.net/companies/sharplight-technologies/2a49963e-5486-407c-87af-d14606822794

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd