483
Advanced Medical Solutions Ltd.Advanced Medical Solutions Ltd. – FDA 483, Jun 23, 2016
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.
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ID · 060f3911-5851-4ed2-85fa-fa1230fecb83
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