Warning Letter — Lion Street Medical, d/b/a Pensar Medical LLC
The FDA issued a Warning Letter to Lion Street Medical, doing business as Pensar Medical LLC, following an evaluation by the Center for Devices and Radiological Health (CDRH).
This affects Lion Street Medical (d/b/a Pensar Medical LLC) and their internal regulatory, quality, and manufacturing departments responsible for device compliance.
The issuance of a formal Warning Letter by CDRH indicates that the firm's responses to previous inspectional findings were likely insufficient to address documented regulatory concerns. This development may lead to increased scrutiny of the firm's quality management system and could potentially impact future product clearances or export certifications if the underlying violations are not remediated to the agency's satisfaction.
Regulatory and QA teams should ensure all active warning letters are reviewed for specific Quality System Regulation (QSR) violations. Operations should verify that all manufacturing and post-market processes align with CDRH compliance standards to mitigate enforcement risks.
FDA Warning Letter issued to: Lion Street Medical, d/b/a Pensar Medical LLC. 08/21/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lion-street-medical-dba-pensar-medical-llc-733015-08212026
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