FDA 483 - SKNV - May 29, 2026

Between May 18 and May 29, 2026, the FDA inspected Sincerus Florida, LLC (doing business as SKNV), an outsourcing facility located in Pompano Beach, Florida. The inspection identified several critical safety and quality control violations that could compromise drug sterility and patient safety. Key issues included inadequate validation of sterile processes, as smoke studies failed to simulate routine operations or properly visualize airflow. Physical deficiencies were also noted in the sterile compounding hoods, including cracks, scratches on HEPA filters, and unidentified sticky residues. The Quality Unit was found to be underperforming, specifically regarding its failure to independently sample finished products or perform adequate risk assessments for manufacturing changes. Additionally, the facility failed to properly investigate multiple patient complaints involving adverse reactions like skin burning and swelling. Other concerns included the lack of testing for harmful microorganisms in non-sterile products and inconsistent documentation of cleaning procedures. These observations were issued under the Federal Food, Drug, and Cosmetic Act and do not represent a final agency determination. The company is required to respond to these findings, either by disputing the observations or by submitting a detailed plan for corrective actions to address the identified deficiencies.