The New Hope Center for Reproductive Medicine

Warning LetterOpen

United StatesIssued Jun 27, 2023Division of Biological Products Operations I

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations0

Issue DateJun 27, 2023

Product TypeBiologics

StatusOpen

Letter Details

Firm: The New Hope Center for Reproductive Medicine
Location: United States
FEI Number: N/A
Country: United States
Issue Date: June 27, 2023
Issuing Office: Division of Biological Products Operations I
Product Type: Biologics
Status: Open

Summary

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.

The New Hope Center for Reproductive Medicine FDA Warning Letter, June 27, 2023