US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP Compliance

City, India, December 23, 2024: In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device manufacturers are enhancing their Good Manufacturing Practice (GMP) compliance, leading to a rise in US FDA inspections in India. The current political scenario and China plus one trend highlight India's growing role as a trusted global supplier in the healthcare and MedTech sector.

According to the FDA's FY 2023 Annual Report, the agency conducted 2,953 inspections globally in fiscal year 2023, comprising 2,499 routine surveillance inspections and 454 for-cause inspections. While specific data for fiscal year 2024 is not yet available, the Government Accountability Office (GAO) reported that the FDA conducted 621 foreign inspections and 444 domestic inspections in fiscal year 2023, indicating a 36% decrease compared to pre-pandemic levels in fiscal year 2019.

In India, the FDA performed 110 routine surveillance inspections and 45 for-cause inspections, totalling 155 inspections during 2023. It's important to note that the FDA's inspection activities are gradually returning to pre-pandemic levels, with a 40% increase in total inspections from fiscal year 2024-25.

To achieve audit success, Indian manufacturers must focus on implementing a robust Good Manufacturing Practice (GMP) compliant with 21 CFR Part 211 (pharma), 21 CFR Part 111 (nutraceuticals) and 21 CFR Part 820 (medical devices), ensuring data integrity, and conducting process and equipment validation to maintain consistency and reliability. They should prioritise staff training, develop a strong Corrective and Preventive Action (CAPA) system, and establish stringent supplier and material controls to ensure traceability and quality. Additionally, manufacturers must implement strong complaint-handling systems, conduct mock audits to ensure inspection readiness and collaborate with regulatory consultants for pre-audit assessments.

A systematic and proactive approach to compliance

As per data, 66% of the small and medium FDA-registered facilities in India receive Form 483 observations or fail to respond on time to 483 observations due to a variety of compliance shortcomings. Here are the key reasons explained by the veteran in this field and FDA consultant Soio George from I3CGlobal. Achieving FDA audit success requires a “systematic and proactive approach” to compliance:

1. Management commitment and resource allocation are critical to the success of any GMP implementation in any FDA-regulated industry. A strong commitment from management ensures that necessary resources—both human and financial—are allocated to maintain and improve the QMS. This includes providing the infrastructure required for operations, such as facilities, equipment, and technology. Additionally, having a dedicated team of qualified Quality Assurance and Regulatory Affairs (QARA) personnel is essential. These professionals ensure compliance with regulatory standards, manage documentation, and oversee audits and inspections. Without the right infrastructure and a skilled QARA team, even the best-laid plans can falter, making their involvement crucial for ensuring product quality and regulatory adherence.

2. Implement a robust QMS aligned with 21 CFR Part 211 (pharma), 21 CFR Part 111 (nutraceuticals) and 21 CFR Part 820 (medical devices). Maintain SOPs, work instructions, and quality records to ensure process control. Employ proper documentation practices and conduct periodic data audits to detect and correct discrepancies. Conduct mock audits to simulate FDA inspections and evaluate readiness. Prepare teams to answer audit queries confidently and provide evidence promptly. If required, address audit findings immediately and submit corrective action plans to the FDA.

3. Perform process validations, including cleaning and sterilisation protocols, to maintain product consistency and safety. Ensure equipment calibration and maintenance are conducted regularly and implement risk-based validation protocols aligned with FDA expectations.

4. Train employees on GMP guidelines, CAPA procedures, and inspection readiness. Maintain training records to demonstrate compliance during audits and organise mock audits to prepare staff for accurate FDA inspections.

5. Implement a strong Corrective and Preventive Action (CAPA) system to address non-conformities. Perform root cause analysis and initiate preventive measures to avoid repeat issues.

6. Qualify and audit suppliers to ensure high-quality raw materials and components. Maintain traceability records for all materials and conduct incoming material testing to verify specifications and control plan compliance. 

7. Poor control over laboratory practices can lead to critical issues, such as inadequate handling of Out-of-Specification (OOS) results, where investigations into testing deviations are insufficient. Additionally, incomplete or non-compliant stability studies fail to meet FDA requirements, jeopardising product quality and regulatory compliance.

8. Labelling and packaging errors, especially for nutraceuticals, can result in mislabelling and misbranding violations. Nutraceutical products often fail to meet labelling requirements under 21 CFR Part 101, leading to misleading claims or incomplete ingredient declarations, which can jeopardise compliance and consumer trust.

9. Establish systems for tracking, investigating, and resolving customer complaints. Report adverse events and implement corrective actions promptly. Continuously monitor product performance through post-market surveillance programs to ensure ongoing compliance.

10. Collaborate and work with firms with previous experience in implementing GMP and pre-audit assessments handling FDA Form 483 responses, and CAPA implementation.

11. On a high level - Leverage Technology for Compliance Utilize electronic systems to streamline documentation, track data integrity compliance, and improve audit readiness. Implement audit management software to monitor findings and corrective actions while digitising quality records for better traceability.

By adopting these strategies, FDA Registered establishments/manufacturers can strengthen compliance, minimise regulatory risks, and achieve sustained FDA audit success.

Conclusion

As Indian pharmaceutical, nutraceutical, and medical device manufacturers work to enhance their GMP compliance and meet the growing demand for high-quality healthcare products, the importance of effective US FDA inspection preparedness cannot be overstated. Achieving FDA audit success requires a comprehensive, proactive approach, including strong management commitment, thorough employee training, rigorous process validation, and robust documentation practices. By focusing on continuous improvement and leveraging technology to streamline compliance efforts, manufacturers can meet regulatory expectations and build a reputation for quality and reliability in the global marketplace. With the increasing presence of the USFDA in India, staying ahead of regulatory demands is crucial for successful audits and maintaining market access, particularly in light of the China plus one policy.