Jiangsu Hengrui Pharmaceuticals received a warning letter from the FDA for quality control department supervision and control in the document and facility design. Jiangsu Hengrui Pharmaceuticals said that this warning letter is related to the FDA483 form received by the company in June, and it is expected that this warning letter will not have a significant impact on the company's performance in 2024. As for product structure, operating income for 10-30 billion yuan products were 401/1288/60 million yuan respectively.
On July 17th, Caixin reporter found on the official website of the FDA that Jiangsu Hengrui Pharmaceuticals received a warning letter for a production site, which listed 2 defects involving quality control department supervision and control in the document and facility design issues. Hengrui Pharmaceuticals responded to Caixin reporters that this warning letter is related to the FDA483 form received by the company in June and is expected to not have a significant impact on the company's performance in 2024. The company will maintain close communication with the FDA and strive to close the warning letter as soon as possible.
Recently, Caixin reporters found on the FDA official website that Jiangsu Hengrui Pharmaceuticals received a warning letter from the FDA for a formulation production site. This warning letter is a follow-up measure for the inspection results of the Huanghe Road No. 38 formulation production site in the Lianyungang Economic and Technological Development Zone from January 8th to January 16th, 2024, which is also the first warning letter received by Jiangsu Hengrui Pharmaceuticals since exporting formulation products to the United States in 2011.
According to Caixin reporters, the warning letter received this time is related to the 483 form disclosed by the FDA website at the beginning of June.
The warning letter shows that on July 11th, the FDA listed 2 defects. The first is that the company's quality management unit failed to fulfill its responsibility to ensure that the produced drug product complies with CGMP and meets the established identification, specification, quality, and purity. The second is that the company failed to operate within a defined area of sufficient size, and there is no separate or specified area, or necessary other control systems to prevent contamination or confusion of the aseptic processing area.
It is worth noting that the defects listed in this warning letter are mainly derived from part of the content listed in the previous 483. Previously, Caixin reporters reported that Jiangsu Hengrui Pharmaceuticals received the FDA483 form in June. This FDA inspection involved a formulation production site in the Lianyungang area. The company has submitted corrective replies and completion tracking reports to the defects raised by the inspection and maintained active communication with the FDA. Issues involved in the 483 form at that time included insufficient sterile protection details management, inadequate cleanliness verification and evaluation details, a loophole in the document management software, and insufficient management of abandoned record files.
Jiangsu Hengrui Pharmaceuticals told Caixin reporters that for what was listed in the previous 483, the company has made improvements and corrections for all defects, such as quality assurance (QA) defects. The company has carried out a risk reassessment of the document management software, created a new document destruction procedure, revised existing procedures, and provided new training to employees. However, the FDA believes that a more comprehensive evaluation and corrective plan should be taken for this issue. The company stated that it has always taken regulatory compliance requirements seriously and will work hard to improve and upgrade comprehensively.
"This Warning Letter is not expected to have a significant impact on the company's 2024 performance." Jiangsu Hengrui Pharmaceuticals stated that the site has a total of 12 generic drugs approved for listing by the FDA, which are not the company's main products. The revenue of products exported to the US market from this site in 2023 was 12.4 million US dollars, accounting for about 0.39% of the company's 2023 operating income ratio. The revenue of products exported to the US market in the first quarter of 2024 was 3.9388 million US dollars (unaudited), accounting for about 0.47% of the company's operating income in the period.
Some industry insiders analyzed that the document issue involved in this warning letter is actually relatively common. Many problems related to documents also exist in clinical trials. Due to the long process time and complex operations, the problem of missing documents may occur. However, professionals need to investigate whether these documents are important on site. The lack of measures to prevent contamination or confusion in the area used to produce aseptic products is a process issue. The FDA generally gives a limited time for companies to make improvements.
Jiangsu Hengrui Pharmaceuticals told Caixin reporters that the company's product exports have not been affected so far. In addition, the company will actively organize domestic and foreign experts and third-party consulting institutions to implement relevant suggestions and maintain close communication with the FDA to strive to close the warning letter as soon as possible.