FDA 483 - SRI Healthcare LLC - July 10, 2025

An FDA inspection of SRI Healthcare LLC, a repacker in Mebane, NC, revealed significant deficiencies in their quality system oversight. The firm failed to conduct required management review meetings and did not perform scheduled quality audits. These issues indicate a breakdown in maintaining the suitability and effectiveness of their quality system, potentially impacting the quality of sterilized kits distributed to medical facilities.