FDA 483 - PACKAGE SOLUTIONS LLC - February 10, 2026

PACKAGE SOLUTIONS LLC, a manufacturer of personal lubricant devices in Pompano Beach, FL, was cited for significant deficiencies in its quality management system. The inspection revealed widespread failures in complaint handling, risk management, and documentation, indicating a lack of control over product quality and regulatory compliance. Repeat observations regarding the absence of Unique Device Identifiers (UDIs) on Class II devices highlight persistent non-compliance.