Zhejiang Huahai Pharmaceutical has hired a former FDA staffer as its new chief quality officer, as the company struggles to resolve compliance issues with the FDA at a key manufacturing facility.
Xuejian Xu, who most recently served as chief quality officer at Hengrui Pharma, joined Huahai under the same title in June, the Zhejiang Province, China-headquartered generics giant said in a July 15 securities disclosure (Chinese, PDF).
Before his two-year stint at Hengrui, Xu was chief quality officer at WuXi Biologics and held similar responsibilities at WuXi AppTec after some time as a manufacturing reviewer at the U.S. FDA’s Office of Generic Drugs.
The appointment comes as Huahai works through a scathing citation the FDA slapped on its manufacturing facility in Linhai, China. Following an inspection in April, the agency issued the site a 24-page Form 483 (PDF) with 13 observations, some of which repeated deficiencies identified in a June 2025 FDA warning letter.
For example, the first issue the FDA flagged in the 2025 warning letter centered on the site’s failure to clean equipment and utensils at appropriate intervals to prevent malfunctions or contamination of the drug product. The same language appeared in the eighth observation of the newly published Form 483.
In addition, the FDA cited deficiencies in the cleaning and disinfection of equipment in aseptic processing areas. The plant failed to prevent potential carryover of contamination from one area to another by allowing for a single clean cloth to wipe multiple surfaces, according to the letter.
In one of the longest observations, detailed over four pages, the FDA said the Linhai facility’s procedures for preventing microbiological contamination of sterile drug products were inadequate.
Huahai was at the center of the infamous 2018 valsartan contamination crisis involving nitrosamine impurities classified as probable human carcinogens.
Despite this legacy issue, the Linhai plant lacked a risk analysis to determine how substances the FDA described as “potential genotoxic and suspected human carcinogenic” came to be present in certain tablets, according to the first observation in the agency’s new Form 483. The agency criticized the plant for using an API that had not been tested for the impurities by either the supplier or Huahai before the company shipped bulk tablets containing the API to the U.S.
Xu came to Hengrui’s rescue in 2024 after a series of manufacturing missteps drew the FDA’s attention. Manufacturing deficiencies at a plant operated by Hengrui's subsidiary, Suzhou Suncadia Biopharmaceutical, led the FDA to reject Hengrui and Elevar Therapeutics’ PD-1 inhibitor, camrelizumab, used in combination with the companies’ VEGFR inhibitor, rivoceranib, as a first-line treatment for liver cancer.
Around the same time, the FDA escalated a prior Form 483 to a warning letter for Hengrui’s small-molecule finished drugs facility in Lianyungang, China.
Following the initial 2024 rejection, the FDA declined to approve the camrelizumab-rivoceranib combo again last year after spotting new issues during a reinspection of the Suncadia plant. Last week, Hengrui said the FDA turned down its application for the third time, citing deficiencies at the rivoceranib plant.