FDA 483 - Sun Pharmaceutical Medicare Limited - September 19, 2025

**FDA 483 Summary for Executives**

**Company:** Sun Pharmaceutical Medicare Ltd. **Inspection Dates:** September 8-19, 2025 **Location:** Halol, Gujarat, India **Facility Type:** Sterile Drug Manufacturer

**Key Violations/Issues:** 1. **Aseptic Practices:** The facility failed to establish and adhere to procedures preventing microbiological contamination in sterile drug production. Observations included operators not sanitizing hands before performing sterile connections and handling sterile equipment, leading to potential contamination risks.

2. **Environmental Control:** Items were transferred from less controlled Grade B environments to highly controlled Grade A areas without proper sanitization, compromising sterility.

3. **Sterilization Validation:** The sterilization cycles for certain equipment were not validated, raising concerns about their effectiveness and potential equipment deterioration.

4. **Operator Practices:** Operators were observed not sanitizing hands before entering critical areas or handling sterile items, and improper handling techniques were noted during interventions and equipment setup.

5. **Contamination Risks:** Instances of potential contamination were noted, such as spraying near critical sampling areas and improper handling of sterile stoppers and vials.

**Regulatory Framework:** The observations are based on FDA regulations governing sterile drug manufacturing, focusing on maintaining aseptic conditions and ensuring product sterility.

**Required Actions:** - Sun Pharmaceutical must address these violations by implementing corrective actions, such as revising aseptic procedures, validating sterilization processes, and enhancing operator training to ensure compliance with FDA standards. - The company is encouraged to discuss objections or corrective actions with FDA representatives and submit detailed plans for remediation.

The FDA's observations highlight critical areas for improvement to ensure compliance and maintain product safety.