Smithstown Light Engineering LimitedAugust 15, 2018

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

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Record Details

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.

Company: Smithstown Light Engineering Limited
Inspection Date: August 15, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Eric M. Padgett (Project Director)

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ID · 17428eaa-cfc0-4fc9-a635-150a2b979586