Loading…
The New Hope Center for Reproductive Medicine, a biologics company operating in the reproductive medicine field, received an FDA warning letter on June 27, 2023, for deviations related to the regulation of human cells, tissues, and cellular products (HCT/Ps). The violations fall under the jurisdiction of the Division of Biological Products Operations I and involve non-compliance with current FDA regulations governing HCT/P manufacturing, processing, or distribution. Based on the limited metadata available, the specific violations and their scope cannot be determined without access to the full warning letter text.