FDA 483 - NATCO Pharma Limited Chemical Division Chennai - June 19, 2025

**FDA 483 Summary for NATCO Pharma Limited**

**Inspection Overview:** - **Company:** NATCO Pharma Limited - **Location:** Rangareddy, Telangana, India - **Inspection Dates:** June 9, 2025 - June 19, 2025 - **Facility Type:** Sterile and Non-Sterile Drug Manufacturer

**Key Violations/Issues:** 1. **Data Integrity and Environmental Monitoring:** - Inadequate review of electronic data for non-viable particle (NVP) monitoring in aseptic processing areas. - Discrepancies between electronic and printed data, with evidence of data manipulation to show compliant results. - Failure to follow Standard Operating Procedures (SOPs) for handling non-conforming NVP results, including lack of incident investigations. - Retesting practices lacked justification and documentation, violating SOPs. - Omission of relevant environmental monitoring data from batch records, hindering quality review.

2. **Maintenance of Equipment and Utensils:** - Observed physical damage and contamination risks in aseptic processing areas, such as rough surfaces, exposed bolt threads, and gaps in equipment, which could compromise drug product safety and quality.

3. **Aseptic Process Validation:** - Inadequate validation of aseptic processes, evidenced by insufficient smoke studies for airflow visualization. - Videos lacked comprehensive visibility and smoke clarity, contradicting acceptance criteria and preventing proper assessment of airflow patterns.

**Regulatory Framework:** The inspection was conducted under the regulatory framework governing drug manufacturing practices to ensure product safety, identity, strength, quality, and purity.

**Required Actions:** NATCO Pharma Limited is required to: - Implement robust data integrity measures and ensure accurate reporting of environmental monitoring data. - Adhere strictly to SOPs, initiate incident investigations for non-conforming results, and document retesting justifications. - Repair and maintain equipment to prevent contamination risks. - Conduct comprehensive and