FDA 483 - WIZCURE PHARMAA PRIVATE LIMITED - December 10, 2025

From December 3 to December 10, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of Wizcure Pharmaa Private Limited at its sterile drug manufacturing facility in Rajasthan, India. The inspection uncovered severe deficiencies in the firm’s ability to ensure the safety and sterility of its products, categorized under the regulatory framework of Current Good Manufacturing Practice (CGMP).

Primary violations centered on systemic data integrity failures and poor laboratory practices. Inspectors discovered that microbiologists discarded samples showing microbial growth and replaced them with unused plates to hide contamination. Furthermore, sterility and antimicrobial effectiveness records were found pre-filled with passing results before testing was completed. The facility also lacked digital audit trails on critical laboratory equipment, and official documents were found discarded in the trash.

Regarding the manufacturing environment, investigators observed visible rust on filling equipment and HEPA filters. Personnel behavior was significantly deficient, with staff observed with exposed skin in sterile zones, touching sterile connections directly with hands, and using mobile phones during aseptic operations. Additionally, the firm failed to conduct required environmental air and surface monitoring.

As a result of these observations, the firm"s leadership must submit a formal response to the FDA. This response must include a detailed corrective and preventive action plan addressing the data falsification, facility maintenance, and aseptic processing failures to ensure future compliance.