Loading…
Innoveix Pharmaceuticals Inc was cited for manufacturing adulterated sterile drug products, including compounded Semorelin/Ipamorelin and AOD-9604 injectable formulations, in violation of the Federal Food, Drug, and Cosmetic Act. The FDA inspection from May 2021 identified serious deficiencies in sterile drug production practices, including the use of unsuitable sterilization equipment for bulk drug solutions that created contamination risks. The company voluntarily recalled the affected products in July 2021 due to lack of sterility assurance, acknowledging the inadequacy of their manufacturing controls.