USFDA emphasises on response over perfection in inspections: Sarah McMullen

Amidst higher inspections from the US drug regulator, the country director of the US Food and Drug Administration (USFDA) said that the agency does not seek 'perfection' during inspections; it rather focuses on how companies approach the inspections. 

Speaking at the Global Pharmaceutical Quality Summit organised by the Indian Pharmaceutical Alliance (IPA), Sarah McMullen, the country director of the India office at the Office of Global Operations of USFDA said: "US FDA does not seek perfection during inspections and instead focuses on how companies respond to the identified issues."

Highlighting the regulatory agency's approach towards inspections, McMullen said that the USFDA focuses on how companies approach the inspection. She emphasised that the investigation, identification of problems, implementation of corrective actions, and subsequent monitoring of effectiveness are critical factors considered by the USFDA.

McMullen stressed the importance of a robust quality system, stating that,  “Observations related to the quality unit are particularly concerning to the agency. As the quality unit impacts all aspects of a company's systems.”

Responding to a query regarding the FDA's focus on addressing industry problems, McMullen highlighted the need for companies to handle issues promptly and effectively. She expressed the agency's interest in companies' efforts to investigate problems comprehensively, identify root causes, implement corrective actions, and ensure the sustained effectiveness of those actions. 

McMullen added, “FDA is approachable and welcomes ideas from the industry because compliance is a shared goal and inspection plays a role in voluntary compliance, but the outreach and the continual engagement between the regulator and industries are the things that we're prioritising.”

According to data analysed by the Indian Pharmaceutical Alliance (IPA), out of the 52 inspections conducted in 2023, 49 resulted in either voluntary action indicated (VAI) or no action indicated (NAI) status. This suggests a high level of compliance among the top 24 drug firms in India represented by the IPA.