Key takeaways
- Firms will need to ensure that their manufacturing sites, suppliers, or service providers in China are prepared for increasing FDA inspections.
- Firms can evaluate readiness for such FDA inspections by focusing on previous findings by FDA in the region and particularly data integrity issues.
- Firms should take proactive measures to audit their data management practices, provide comprehensive training to their staff on applicable FDA regulations and guidance, and conduct mock inspections.
- Firms contemplating acquisition of entities that contract with Chinese CROs or manufacturing facilities or suppliers will need to place particular focus on evaluating the FDA compliance history and status of such facilities.
In more detail
FY 2024 saw a significant increase in the number of FDA's foreign inspections in China, with 159 inspections to date as reported by FDA.2 Of these 159 inspections, 106 (66.7%) were drug inspections3 and 53 (33.3%) were device inspections. 12 (7.5%) inspections were classified Official Action Indicated (OAI),4 meaning that the inspection reports for those inspections recommended regulatory or administrative actions.5 In comparison, the number of FDA inspections in China for drug and devices over the preceding three years, immediately following the pandemic, (i.e., 2021-2023) ranges from eight in FY 2022 to 58 in FY 2023.
Below is a chart summarizing the number of the FY 2021-2024 FDA inspections in China, as well as the number of inspections classified as OAI. We are now witnessing a significant rise in FDA inspections in China in the FY 2024.
Figure 1. Increasing FDA Drug and Device Inspections in China
| |
FY 2021 |
FY 2022 |
FY 2023 |
FY 2024 |
| Number of FDA drug and device inspections in China |
18 |
8 |
58 |
159 |
| Inspections classified OAI |
4 |
3 |
6 |
12 |
There is also reason to believe that the number of FDA foreign inspections in China will continue to grow. Notably, in FY 2019, the FDA conducted 227 drug and device inspections in China, a figure that remains significantly higher than the 159 inspections reported so far in FY 2024. Since 2023, Congress has also been pressing the FDA over inadequate inspections in China and India. In a June 2024 letter to the FDA Commissioner, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and other representatives highlighted variations in domestic and foreign inspection outcomes. They specifically requested the FDA to provide detailed information on inspections conducted in China and India.7
In spite of the significant increase in inspectional activity, more FDA enforcement actions will likely to follow. For example, in two recent FDA Warning Letters issued in September 2024 to two nonclinical testing laboratories based in China, the agency cited both for laboratory oversight failures and animal care violations that raise concerns about the quality and integrity of data generated by the labs.8 The main observations identified included:
- Failures in data management, quality assurance, staff training and oversight;
- Failure to accurately record and verify key research data, which brings into question the quality and integrity of safety data collected at the facilities; and
- Failure to provide adequate care for the animals, and both firms failed to provide adequate identification and recording of the animals used in the labs' testing.
Since these two laboratories offer third-party testing and validation data services to device manufacturers for their premarket submissions to the FDA, the inspection findings could impact the FDA's premarket review of these submissions.
Similarly, in another FDA Warning Letter issued in July 2024 to a Chinese drug manufacturer for violations from cGMP and these observations include:9
- Failure to provide adequate oversight and ensure the reliability of quality data of the finished drug products manufactured;
- Failure to perform operations within separate and specially defined areas, which caused a lack of adequate protection against contamination or mix-ups in aseptic processing areas; and
- Failure to ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured.
All the above examples we referenced involve significant data integrity violations. This issue appears to be a recurring trend that is raising concerns for the FDA during their inspections in China. Data integrity is crucial for ensuring the reliability and trustworthiness of data submitted to regulatory agencies and product safety. Given the FDA's heightened focus on data integrity, it is imperative for pharmaceutical and medical device companies with operations in China to rigorously assess and enhance their data management practices.
1 Drug Safety: FDA should take additional steps to improve its foreign inspection Program, US GOVERNMENT ACCOUNTABILITY OFFICE, January 7, 2022.
2 Based on data gathered on FDA's Inspections Data Dashboard.
3 Please note that drug and biologics inspections for FY 2024 were group together for purposes of this alert.
4 Id.
5 Inspections Database Frequently Asked Questions, FDA, May 11, 2020.
6 E&C Republicans Press FDA Over Inadequate Inspection of Drug Manufacturing in India and China.
7 E&C Republicans Press FDA Again for Information Regarding Foreign Inspection Program
8 FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices.
9 FDA Warning Letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd., MARCS-CMS 679790 — July 11, 2024.
