FDA 483 - Sunshine USA, LLC - April 28, 2025

Sunshine USA, LLC, a manufacturer in Johnson City, TN, was inspected by the FDA and received a Form FDA 483 with four observations. The inspection revealed significant issues with the firm's quality system, including inadequate procedures for complaint handling, corrective and preventive actions, equipment calibration, and employee training. Several of these observations were repeats from a previous inspection, indicating a persistent lack of compliance.