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

Source: https://www.keypedia.com/records/483/natco-pharma-limited-chemical-division-chennai/2ce2ef17-813a-446e-9898-a324eb76b89a

> FDA 483 for NATCO Pharma Limited Chemical Division Chennai on June 19, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NATCO Pharma Limited Chemical Division Chennai
- Inspection Date: 2025-06-19
- Product Type: Drugs
- Office Name: Office of Inspections and Investigations
- Summary: **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

## Related Documents

- [483 - 2025-11-21](https://www.keypedia.com/records/483/natco-pharma-limited-chemical-division-chennai/ccd7fa17-7d9c-41c1-b8eb-fad2bb3518c9)

## Related Officers

- [Sen Lin](https://www.keypedia.com/people/sen-lin/3ab3159c-49a6-4258-8de7-2c4d14d6429f)
- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/natco-pharma-limited-chemical-division-chennai/c2978c98-d900-4777-9b55-7c62f09edfe0

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8