FDA WARNING_LETTER - WIZCURE PHARMAA PRIVATE LIMITED - December 10, 2025

Wizcure Pharmaa Private Limited, located in Rajasthan, India, received an FDA warning letter following an inspection conducted from December 3 to 10, 2025. The investigation revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the firm"s sterile drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

The most severe issues involved systemic data integrity breaches. FDA investigators discovered that laboratory personnel deliberately discarded microbial plates showing growth and replaced them with clean plates to misrepresent the sterility of the manufacturing environment. Additionally, laboratory forms were found pre-filled with passing test results before the actual testing was completed. The inspection also identified critical physical deficiencies, including a lack of barriers between sterile filling lines and non-sterile areas, the presence of rust on critical manufacturing equipment and HEPA filter grids, and inadequate airflow studies used to validate contamination controls.

In response to these findings, the company has suspended production for the U.S. market and initiated a voluntary product recall. The FDA has also placed the firm on an import alert. To regain compliance, Wizcure is required to engage an independent consultant to conduct a comprehensive audit and a retrospective data integrity investigation. The company must provide the FDA with a detailed risk assessment regarding the safety of products already distributed, a robust remediation plan for facility design and equipment maintenance, and evidence of enhanced management oversight to ensure the accuracy and reliability of all manufacturing data.