K. W. Griffen Company DBA Biomed Packaging Systems – FDA 483, May 16, 2025

K.W. Griffen Company in Norwalk, CT, was inspected by the FDA, revealing six observations primarily concerning the manufacturing of their 4% Chlorhexidine Surgical Scrub Brush-Sponge and Nail Pick combination product. Deficiencies included a lack of process validation, inadequate equipment qualification documentation, and significant issues within the quality control unit regarding procedures for deviations, stability data review, and supplier qualification. Additionally, the firm failed to conduct cleaning validation studies, properly manage retain samples, and control access to labeling materials, indicating a broad lack of cGMP compliance.