The US Food and Drug Administration (FDA) continues to identify serious data-integrity violations at Indian pharmaceutical manufacturing facilities and clinical research organisations (CROs). These violations have raised concerns over the reliability of information submitted by companies for regulatory assessments, a senior FDA official said. Constance Richard-Math, the FDA’s Deputy Country Director in India, said inspectors continue to uncover violations even eight years after the agency issued guidelines on data integrity. In several cases, the affected studies and tests must be repeated to generate reliable data and meet regulatory requirements.
Inspections Uncover Destruction of Critical Records
The FDA’s routine and unannounced inspections have also revealed instances of companies discarding large volumes of critical records related to analytical testing, manufacturing procedures and storage conditions. According to Richard-Math, inspectors have found cases in which truckloads of important documents were destroyed, including records disposed of using paper shredders. Such practices undermine data reliability and create challenges for developing resilient pharmaceutical supply chains. Furthermore, FDA inspections continue to identify unacceptable, and in some cases grossly insanitary, conditions at manufacturing facilities. During her presentation, Richard-Math shared photographs highlighting dirty and poorly maintained manufacturing environments.
FDA Urges Drugmakers to Strengthen Supply Chain Oversight
Richard-Math urged pharmaceutical manufacturers to extend their compliance oversight beyond their own facilities and closely monitor suppliers, vendors, contractors and other supply chain partners. She emphasised that companies must understand who operates across their supply chains and take appropriate action whenever they identify facilities that fail to meet acceptable manufacturing and quality standards. She also cautioned companies against overlooking violations at third-party facilities.
FDA Regulatory Actions During FY2025
The FDA’s regulatory actions during FY2025 further highlight the importance of compliance across pharmaceutical manufacturing operations. During the financial year, the agency issued 39 Official Action Indicated (OAI) classifications, which may include warning letters. Meanwhile, 149 inspections resulted in voluntary actions, while 53 inspections concluded without regulatory action. These figures underline the need for pharmaceutical manufacturers to strengthen quality management systems, maintain accurate documentation and address compliance gaps proactively.
Early Intervention Key to Building Compliance Culture
To establish a stronger compliance culture, Richard-Math advised pharmaceutical companies to identify warning signs early and resolve issues before they lead to product failures, recalls or medicine shortages. Supporting this concern, a survey-based white paper by Vector Consulting Group, titled The Compliance Spiral in Pharma Manufacturing, highlighted the operational challenges associated with incident and investigation management.
The report found that incident management and investigation processes can place considerable pressure on manufacturing operations, affecting batch release timelines and consuming significant management attention. It also noted that every manufacturing plant surveyed had a backlog of incidents awaiting closure. As reported by ETPharma.com, these findings highlight the importance of robust data governance, effective investigation processes and stronger quality oversight to ensure regulatory compliance and maintain the reliability of pharmaceutical manufacturing and supply chains.
