FDA 483 - XL PRECISION TECHNOLOGIES LTD - August 29, 2025

XL PRECISION TECHNOLOGIES LTD, a medical device manufacturer in Stockton-On-Tees, United Kingdom, was cited for significant deficiencies in its quality system. The FDA inspection revealed inadequate establishment and implementation of corrective and preventive action procedures, as well as insufficient validation of a critical passivation process. Additionally, the firm failed to adequately establish procedures for monitoring and controlling process parameters for this validated process.