FDA 483 - SRI Healthcare LLC - July 10, 2025

An FDA inspection conducted at SRI Healthcare LLC from July 8-10, 2025, revealed significant issues related to the company's quality management system. The inspection, documented in an FDA Form 483, highlighted two primary observations. First, management with executive responsibility failed to conduct regular reviews of the quality system's suitability and effectiveness. Specifically, SRI Healthcare LLC did not perform required Management Review meetings in 2023 and 2024, deviating from their own Standard Operating Procedure which mandates bi-annual reviews. This indicates a lapse in oversight of critical quality processes. Second, the company failed to perform scheduled quality audits. A crucial quality audit for June 2025 was missed, leading to a lack of review for numerous essential procedures, including complaint handling, medical device reporting, corrective and preventive actions, and sterility release records. The document noted that this oversight could potentially compromise the quality of sterilized kits distributed to medical facilities. Furthermore, SRI Healthcare LLC did not generate a nonconformance report or initiate corrective actions for the missed audit, as required by their internal work instructions. These observations indicate non-compliance with established quality system regulations, requiring the firm to implement corrective measures to address the identified deficiencies and ensure ongoing regulatory adherence.