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# CGMP Violations at India’s Sun Pharmaceutical
- URL: https://www.fdaweb.com/cgmp-violations-at-indias-sun-pharmaceutical/
- Published: 2023-01-10T12:00:00.000Z
- Updated: 2026-09-14T18:11:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153501

A 4/26-5/9/22 FDA inspection at the Sun Pharmaceutical Industries drug manufacturing facility in Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/15/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-12152022?ref=fdaweb.com) says specific violations were:

- failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failing 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;
- failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance;
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
- failing 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.

FDA also says a sample of a redacted drug capsule was adulterated because it failed to meet specifications for dissolution.

“Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP,” the letter says. “In addition to the lack of effective oversight of production operations to ensure reliable facilities and equipment, we found your quality unit is insufficiently resourced or enabled with authority to carry out its responsibilities. Furthermore, internal communications and systems were not implemented by management to ensure all levels of the company can effectively identify major quality risks so they are promptly escalated to senior management, whenever needed. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.”

FDA strongly recommends that Sun engage a qualified consultant to assist it in meeting CGMP requirements. It placed Sun on an import alert 12/7/22.

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