FDA 483 - Grato Holdings, Inc. - July 14, 2022

Grato Holdings, Inc., a homeopathic manufacturer in Woodbine, IA, was cited for significant deficiencies across its quality systems during an FDA inspection. Observations included inadequate raw material testing, poor contamination control in manufacturing areas, insufficient process and cleaning validations, and deficient laboratory controls for microbiological testing. These issues indicate a lack of robust controls to ensure the identity, strength, quality, and purity of their drug products.