# FDA 483 - Smithstown Light Engineering Limited - August 15, 2018

Source: https://www.keypedia.com/records/483/smithstown-light-engineering-limited/17428eaa-cfc0-4fc9-a635-150a2b979586

> FDA 483 for Smithstown Light Engineering Limited on August 15, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smithstown Light Engineering Limited
- Inspection Date: 2018-08-15
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Smithstown Light Engineering Limited, a medical device manufacturer in Shannon, Ireland, identified issues with documentation approval processes. The firm failed to ensure that device history records and corrective action reports included proper approving official signatures. This indicates a deficiency in their quality system regarding record control and authenticity.

## Related Documents

- [483 - 2018-08-13](https://www.keypedia.com/records/483/smithstown-light-engineering-limited/735b23f1-3ecb-4418-a19f-1731106d26d0)

## Related Officers

- [Project Director](https://www.keypedia.com/people/eric-m-padgett/a42150bc-aa7f-4076-8a68-af47ff465bac)

Company: https://www.keypedia.com/companies/smithstown-light-engineering-limited/c340fd88-e98a-4a68-8bff-7c0c5b546f22

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