FDA 483 - Sunstar Americas, Inc. - February 10, 2023

Sunstar Americas, Inc., a medical device manufacturer in Schaumburg, IL, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures during an FDA inspection. The firm failed to adequately document medical device recalls and did not satisfy requirements for CAPA records opened in response to a previous FDA Warning Letter, including the use of an unapproved "FDA Tracker" and numerous expired due dates. This observation is a repeat of a previous inspectional finding, indicating persistent and severe quality system issues.