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

The FDA inspected OHM Pharma, Inc. from May 14-23, 2019, identifying significant violations of CGMP regulations for finished pharmaceuticals (21 CFR Parts 210 and 211), rendering drug products adulterated. Additionally, serious violations of CGMP for dietary supplements (21 CFR Part 111) were found, making dietary supplements like Jambol Seed Syzygium Jambolanium and (b)(4) adulterated. These dietary supplements were also misbranded under 21 CFR 101.

Key drug CGMP violations include: 1. Failure to maintain clean and sanitary facilities (21 CFR 211.56(a)), with observed white residue and inadequate cleaning procedures, especially concerning non-dedicated equipment for products including those for infants and children, and potentially toxic ingredients like boric acid. 2. Failure to establish scientifically sound laboratory controls (21 CFR 211.160(b)), including non-representative water sampling, deficient microbiological test methods (lacking growth promotion, method suitability, and sufficient detail for finished product testing), and inadequate responses to these issues. 3. Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)), with unvalidated manufacturing processes, inadequate batch records lacking specificity (e.g., dry times, pellet impregnation), and insufficient process validation plans