FDA 483 - OHM Pharma, Inc. - May 23, 2019

OHM PHARMA INC. in Mineral Wells, TX, a manufacturer of homeopathic drugs, received a Form 483 with significant observations related to quality control, laboratory practices, and manufacturing processes. The inspection revealed deficiencies in documentation, investigation of out-of-specification results, control of records, equipment calibration, and process validation. These issues indicate a lack of adequate controls to ensure the quality, purity, and safety of their drug products.