483
Sotera Wireless, Inc.Sotera Wireless, Inc. – FDA 483, Jun 19, 2018
Record Details
An FDA inspection of Sotera Wireless, Inc., a Class II medical device manufacturer in San Diego, CA, revealed two significant observations. The firm failed to provide justification for not reporting a correction or removal action to the FDA, specifically regarding a complaint about their Visi Mobile Monitoring System. Additionally, procedures for corrective and preventive actions were found to be inadequately established, with an open CAPA not being investigated or closed in a timely manner.
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ID · 41815ec0-732c-4759-a813-b83b76080a36
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