FDA 483 - The Phallofill Clinics LLC - August 08, 2025

The Phallofill Clinics LLC in Dallas, TX, an initial importer/distributor of the Class II medical device PhalloSleeve, was cited with four observations during an FDA inspection. The firm failed to establish and implement critical quality system procedures, including those for Medical Device Reporting (MDR), complaint handling, corrective and preventive actions (CAPA), and finished device acceptance activities. These deficiencies indicate significant gaps in the firm's quality management system.