The US Food and Drug Administration (FDA) has criticised the state of Chinese pharma company Jiangsu Hengrui’s facilities in a newly released 483 form.
In January, the agency inspected Jiangsu’s manufacturing site in the Chinese city of Lianvungang, Jiangsu province and observed a range of concerns.
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Jiangsu’s product portfolio includes anti-tumour drugs, surgical drugs, contrast agents, angiomyocardiac drugs, and antibiotics, according to GlobalData’s pharmaceuticals database. The company has pipeline products in development for the treatment of conditions including cancer, Crohn’s disease, anaemia, diabetes, and atopic dermatitis.
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The writeup by FDA investigator Arsen Karapetyan, and division director for the Center for Drug Evaluation and Research (CDER), Qiao Bobo, included concerns around cleanliness and quality controls. It was observed that the facility’s procedures to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilisation process.
The FDA report deemed cleaning validation studies for equipment, including vials and stoppers, inadequate, and stated that worst-case contaminant (hardest to clean products) determinations did not take into consideration the concentrations of contaminants for all equipment.
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By GlobalDataIn addition, parenteral drug products awaiting destruction in the facility’s waste area were found not to be secure, with the inspectors noting that this area was bordered by a fence of approximately 3.5ft in height and located directly across from a public street. An alarm intended to secure the fence was found not to be functional during the inspection.
Regarding the site’s quality control unit, the report observed that it lacked responsibility to approve all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.
“During the walkthrough of our inspection on 08/01/2024, we observed original executed pages of batch records, validation reports, change controls which had been discarded in a waste bin,” the report said. Karapetyan wrote, “When these original records found in the waste bin were compared to the archived official records, the information, such as production data, did not always match.”
A Hengrui Pharma spokesperson told Pharmaceutical Technology, the company has submitted an action plan and several progress reports, in response to the 16 January Form 483 while maintaining active communication with the FDA.
The Hengrui Pharma spokesperson further said: “Patient safety is always our top priority at Hengrui Pharma, and we take regulatory compliance seriously. We will continue to do everything we can to support the FDA’s ongoing evaluation and collaborate with them to address their observations as soon as possible.”
The FDA’s critiques arrive as the US government prepares to launch the BIOSECURE Act. The new legislation aims to prevent ‘foreign adversary biotech companies’ from receiving US federal funding, as per a government document. The act highlights key Chinese companies such as WuXi AppTec, BGI, MGI, and Complete Genomics, naming them as risks to US national security.
Update: This story was updated on 7 June with a statement from a Hengrui Pharma spokesperson.
