Mission
“The mission of the Beijing-based office is to help ensure the safety, quality, and effectiveness of medical products and food produced in China for export to the United States,” Ray explained. This mission is carried out through risk-based inspections, regulatory engagement, and continuous monitoring of China’s pharmaceutical landscape.
China’s Expanding Role in Global Manufacturing
Ray highlighted that China remains a top contributor to the US FDA’s global drug manufacturing catalog. “China is among the top five countries, ranked third, based on the number of drug sites in FDA’s catalog,” he noted. Over 80% of these facilities are located in eastern provinces such as Shanghai, Jiangsu, Zhejiang, Shandong, and Guangdong.
A significant spike in facility registrations occurred in 2021, which Ray attributed to the COVID-19 public health emergency, noting that the surge was largely driven by increased demand for hand sanitizers during that period.
Resuming Inspections Post-Pandemic
The pandemic led to a sharp decline in US FDA inspections worldwide, largely due to travel restrictions and other challenges related to the COVID-19 public health emergency. Ray explained that inspection activity dropped significantly between 2020 and 2022. However, he noted that inspections began to pick up again in 2023, with a marked increase in 2024, indicating a return to more routine regulatory oversight in the region.
Quality Management Maturity (QMM): Raising the Bar
A key highlight of the presentation was the US FDA’s Quality Management Maturity (QMM) initiative. “A root cause for many drug shortages is the absence of incentives for manufacturers to strive for more than simply meeting CGMP regulations,” Ray noted.
The QMM program is designed to motivate drug manufacturers to adopt quality management practices that extend beyond basic compliance, with a focus on patient-centered approaches, continuous improvement, and strengthening supply chain reliability. In 2024, the US FDA introduced a prototype QMM assessment protocol and conducted evaluations at nine volunteer facilities. According to Ray, these assessments are intended to help CDER determine whether the prototype tool effectively measures an establishment’s quality management maturity and provides useful, actionable feedback.
Beyond Inspections: A Toolkit for Oversight
Ray emphasized that inspections are just one part of the US FDA’s broader oversight strategy. Other tools include denying entry through US ports via Import Alerts, reviewing compliance history, analytical testing, remote regulatory assessments, and the work of the Health Fraud Team.
The Foreign Unannounced Inspection Pilot
One of the most notable initiatives discussed was the Foreign Unannounced Inspection Pilot (FUIP). “This pilot aims to enhance workforce development activities and assess the effectiveness of various inspection notification types—specifically: unannounced, short-notice, and pre-announced inspections,” Ray said. The pilot, launched in both India and China, reflects a broader effort to improve regulatory responsiveness in the global pharmaceutical supply chain.
Addressing Drug Shortages
Ray also addressed the persistent issue of drug shortages. “Drug shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations,” he said. He noted that sterile injectables remain the most affected category, accounting for 61% of shortages in 2023.
He stressed the importance of early communication: “Early, informative notifications are the best tool FDA has to help prevent a shortage from occurring and to mitigate the impact of an unavoidable shortage.
Responding to FDA-483 Observations
Ray reminded attendees of the importance of responding to Form FDA-483, which outlines inspectional observations. “Communicating with FDA after your inspection is important so that we understand any corrective actions and responses to any objectionable conditions that may have been observed during the inspection,” he said.
He encouraged firms to submit responses within 15 business days and to include documentation such as corrective and preventative actions (CAPAs), investigation reports, and risk assessments. “Patient safety must be addressed, and the root cause of the observation(s) must be identified,” he added.
Guidance and Resources for Industry
Ray concluded by encouraging industry professionals to stay informed through the US FDA’s extensive online resources. “When giving presentations, I always remind industry to constantly monitor our website and review the new guidance documents published which are relevant to the work you are performing,” he said.
He highlighted recent guidance documents on topics such as nitrosamine impurities, advanced manufacturing technologies, and the use of AI in regulatory decision-making.
Final Thoughts
In closing, Ray emphasized the US FDA’s commitment to collaboration and transparency. “FDA has many innovative ways to interact with the agency and support firm quality initiatives,” he said. “The FDA’s website contains countless resources available to help industry better understand the FDA’s current thinking on many different topics.”
Disclaimer
This is an informal summary of a presentation on 26 May 2025 at the 2025 ISPE China Conference in Shanghai, China. It has not been vetted by any of the agencies or regulators mentioned in this article, nor should it be considered the official positions of any of the agencies mentioned.
