FDA 483 - Grato Holdings, Inc. - September 19, 2025

Grato Holdings, Inc. in Woodbine, IA, received an FDA Form 483 for deficiencies in its equipment and utensil cleaning procedures. The firm failed to scientifically assess the adequacy of its cleaning methods, especially for new raw materials like progesterone, and did not update its risk matrix to prevent contamination from various substances, including hormones and pathogenic organisms. These issues indicate a risk of contamination that could compromise drug product safety, identity, strength, quality, or purity.