FDA 483 - Kath Khemicals LLC - April 03, 2025

An FDA inspection of Kath Kchemicals LLC in Macomb, MI, revealed significant deficiencies in their manufacturing practices for drug products, including McD Foaming Antibacterial Hand Soap. The firm lacked a functional quality control unit, failed to perform essential identity, stability, and microbial testing, and had inadequate production and process controls. Many of these issues, such as the absence of proper testing and incomplete batch records, were repeat observations from previous inspections, indicating a persistent failure to comply with good manufacturing practices.