FDA 483 - Instrumedical Technologies Inc - February 26, 2025

Instrumedical Technologies Inc. in Warsaw, IN, was inspected from February 24-26, 2025, and received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the control of nonconforming products and the maintenance of device master records. These issues indicate a lack of adequate procedures for rework, nonconformance evaluation, and established production process specifications for cleaning.