Advanced Medical Solutions Ltd.June 23, 2016

FDA 483 - Advanced Medical Solutions Ltd. - June 23, 2016

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Record Details

Advanced Medical Solutions Ltd., a medical device manufacturer in Winsford, United Kingdom, was cited for significant deficiencies during an FDA inspection. Observations included failure to report a device-related risk to health involving switched instructions for use, inadequate design history file documentation for a Silver Hydrogel device, and insufficient validation of key production processes.

Company: Advanced Medical Solutions Ltd.
Inspection Date: June 23, 2016
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Jude C. Dike

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ID · 060f3911-5851-4ed2-85fa-fa1230fecb83