FDA 483 - Piccguard, LLC - February 27, 2025

Piccguard, LLC, a medical device manufacturer in Sheboygan, WI, was inspected and cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures across several critical areas, including purchasing controls, design history file maintenance, design change management, corrective and preventive actions, and risk analysis for its Class II Tamper-Evident Catheter Access Covers (PICC Guards). These issues indicate a systemic lack of adherence to established quality system regulations.