FDA 483 - Cornerstone Medical Associates, Inc. - September 03, 2025

During a facility inspection conducted from September 2 to September 3, 2025, the U.S. Food and Drug Administration (FDA) identified significant operational failures at Cornerstone Medical Associates, Inc., located in Fresno, California. The inspection, overseen by President and Owner Adam C. Sherwood, focused on the establishment"s handling of human cells, tissues, and cellular and tissue-based products. The primary violation cited in the FDA Form 483 involves the failure to record and maintain storage temperatures for these sensitive medical products. Specifically, the investigator found that from October 10, 2023, through January 5, 2025, the firm did not monitor or document the storage environment for various human tissue products received during that period. This regulatory oversight was documented under the authority of Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which ensures that products are held under conditions that prevent contamination and protect public health. Although the observations do not represent a final agency determination, the company is expected to review these findings and provide a formal response. Cornerstone Medical Associates must implement corrective actions to establish consistent temperature monitoring and documentation protocols to ensure the biological integrity and safety of the human tissues they distribute. A failure to address these concerns adequately could result in further regulatory enforcement.