FDA 483 - Immuno Diagnostic Center, Inc - February 12, 2025

Immuno Diagnostic Center, Inc. in Dallas, TX, was inspected and received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning equipment maintenance, calibration, corrective and preventive actions, nonconforming product control, supplier management, and document control. These issues indicate a lack of established and implemented procedures crucial for ensuring product quality and regulatory compliance.