Clayens Crystal Lake, LLC – FDA 483, Apr 2, 2026

Clayens Crystal Lake, LLC, a contract medical device manufacturer in Crystal Lake, IL, was inspected by the FDA from March 30 to April 2, 2026. The inspection revealed deficiencies in the firm's corrective action procedures, specifically regarding the documentation and implementation of actions to address nonconformities and complaints. Issues included inadequate root cause analysis, failure to escalate high-risk assessments to CAPA, incorrect risk assessments, and incomplete investigations.