Loading…
OSRX, Inc., a registered outsourcing facility in Missoula, Montana, produced compounded sterile drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for regulatory exemptions. During an FDA inspection conducted October 16-25, 2024, investigators found serious deficiencies in the facility's practices for producing drugs intended to be sterile, which created patient safety risks. The facility's drug products violated the FDCA by not complying with outsourcing facility requirements necessary to maintain exemptions from drug approval requirements and labeling provisions.