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# CGMP Issues at India’s Wizcure Pharmaa
- URL: https://www.fdaweb.com/cgmp-issues-at-indias-wizcure-pharmaa/
- Published: 2026-07-06T12:00:00.000Z
- Updated: 2026-09-14T13:42:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161404

A 12/3-12/10/2025 FDA inspection at the Wizcure Pharmaa Private Limited drug manufacturing facility in Rajasthan, India, fund significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/24 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wizcure-pharmaa-private-limited-726378-06242026?ref=fdaweb.com) says the specific violations were:

- failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failure to perform operations within specifically defined areas of adequate size, and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas;
- failure to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
- failure to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs Wizcure manufactures. FDA acknowledges that Wizcure is using an independent third-party consultant to audit its operation and assist it in meeting FDA requirements. It also acknowledges Wizure’s commitment to suspend production of all over-the-counter drug products for the U.S. market and to recall all drugs in current distribution in the U.S.

The agency recommends that Wizcure retain a qualified consultant to perform a comprehensive six-system audit of the company’s entire operation and assist it in meeting CGMP requirements.

FDA placed all of the company’s drugs and drug products offered for import into the U.S. on a 12/23/2025 Import Alert.

Wizcure was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.