The FDA on Tuesday released a warning letter sent to China-based drugmaker Jiangsu Hengrui Pharmaceuticals, finding the company failed at multiple levels to ensure its Good Manufacturing Practice (GMP) records were accurate.
The warning letter was sent earlier this month, and followed a similarly critical Form 483 that showed how the agency’s 9-day inspection at the Lianyungang, China, manufacturing site documented “serious quality assurance (QA) deficiencies,” with inspectors finding discarded GMP records “stacked in a bag underneath a vehicle and in a nearby trash can.”
The FDA also found that the site’s production manager had “unrestricted access to blank production batch records and other CGMP documents without QA issuance,” meaning that the company was not “exercising its basic responsibilities for the oversight and control over the adequacy and reliability of all CGMP data.”
Jiangsu Hengrui says on its website that it has a €1.4 billion ($1.5 billion) licensing agreement with Merck KGaA, as well as a deal worth up to $6 billion with the US-based startup Hercules Pharmaceuticals regarding its potential GLP-1 portfolio. Merck KGaA and Hercules did not immediately respond to requests for comment.
A spokesperson for Jiangsu told Endpoints News via email that the company received the warning letter and they will respond to the FDA.
“In response to the related Form 483 issued in January 2024, Hengrui Pharma has already submitted an action plan and several progress reports,” the spokesperson added, “The observations identified at the Huanghe Road site are isolated to this facility, and after a comprehensive investigation and evaluation, we have determined the issues raised in the warning letter have not affected the quality or safety of the products manufactured at this site. As of now, the export of products from this site has not been impacted.”
The warning letter also identified issues with the Jiangsu site’s document management policies, noting that when production employees recorded an “error,” the production manager “printed a blank copy and had the employee transcribe the information on the new record and discarded the old record.”
“There is no assurance that archived data is original or accurate,” the FDA said.
The agency also questioned whether the facility’s aseptic manufacture of sterile drugs was assured, noting that the company’s response to the FDA’s questions was inadequate.
Editor’s note: Updated with comment from Jiangsu Hengrui.