FDA Posts Warning Letter to Hisun for Data IssuesBy
The US Food and Drug Administration (FDA) has posted a Warning Letter on its website to Zhejiang Hisun Pharmaceutical Co., Ltd., a Chinese pharmaceutical company for good manufacturing practice (GMP) violations relating to data integrity at the company’s drug manufacturing facility in Taizhou City, Zhejiang Province, China. The letter was issued in response to an inspection conducted at the facility from March 2 to March 7, 2015.
The agency cited several violations in relation to active pharmaceutical ingredient (API) manufacturing. Among the violations, during the inspection, FDA said that its investigators discovered a lack of basic laboratory controls to prevent changes to the fiirm's electronically stored data and paper records and that ther firm relied on incomplete records to evaluate the quality of your drugs and to determine whether thedrugs conformed with established specifications and standards. The agency also said that the firm routinely re-tested samples without justification and deleted analytical data., and that its inspectors bserved systemic data manipulation across the facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs.
The agency said that its concerns about deletion of data were heightened by the significant number of customer complaints for subpotency and out-of-specification impurity levels from 2012-2014.
The agency acknowledged that the company hired a third-party consultant, set up user access restrictions, and upgrade computerized systems with audit trails. “However, simply activating audit trail functions and instituting password controls are insufficient to correct the broad data manipulation and deletion problems observed at your facility and to prevent their recurrence.,” said FDA in its letter.
The FDA is requesting from the company a comprehensive investigation and evaluation, including conclusions about the extent of data integrity deficiencies and their root causes, which may involve record control, contemporaneous recording, deletion of data, and other data integrity deficiencies. It is also requesting a risk assessment of how the observed deficiencies may affect the reliability and completeness of quality information available for the company’s drugs as well as a management strategy that includes a detailed global corrective action and preventive action plan.
Because of the findings of the FDA inspection, firm was placed on import alert (Import Alert 66-40) on September 9, 2015 for the facility.
In 2012, Hisun and Pfizer launched Hisun-Pfizer Pharmaceuticals Co., Ltd., a joint venture formed between the two companies to develop, manufacture and commercialize off-patent pharmaceutical products in China and global markets.