FDA WARNING_LETTER - Red Mountain Inc - October 11, 2018

The FDA inspected Red Mountain Inc.'s drug manufacturing facility from October 2-11, 2018, identifying significant CGMP violations. The firm's drug product is adulterated under 21 U.S.C. 351(a)(2)(B) and its product, Bioven, is misbranded under 21 U.S.C. 353(b).

Key violations include: 1. **Failure to establish a Quality Control Unit (QCU)** (21 CFR 211.22(a)): Red Mountain Inc. lacked quality oversight for manufacturing finished homeopathic drug products, including those with potentially toxic ingredients like snake venom. They released products without an established QCU, lacked written procedures for QCU responsibilities, and failed to approve or reject components, materials, and products. The firm also did not qualify its contract manufacturing organization (CMO). 2. **Failure of QCU to approve procedures/specifications** (21 CFR 211.22(c)): The firm failed to establish, review, and approve procedures impacting drug product safety, identity, strength, quality, and purity. For example, a "Procedures for Incoming Bioven Handling, Storage, and Shipping" document was not signed by quality personnel, and no other approved SOPs existed. There was also no documentation or procedures for label examination, receipt, handling, or approval.