FDA 483 - OHM Pharma, Inc. - July 29, 2022

OHM Pharma, Inc. in Mineral Wells, TX, was cited with six observations on a Form 483 following an inspection of its dietary supplement manufacturing facility. The firm failed to establish and follow product specifications, released out-of-specification products, and did not adequately confirm component identity or use scientifically valid testing methods. Additionally, deficiencies were noted in master manufacturing records and hand-washing facilities, with several issues being repeat observations.