The US Food and Drug Administration (FDA) made the suggestion in a warning letter published this week. The document also details problems observed at Zhejiang’s active pharmaceutical ingredient (API) manufacturing facility in June last year.
During the visit to the site - which is operated by Zhejiang 's Xinchang Pharmaceutical division - agency inspectors saw staff backdating API quality test results and conducting unofficial tests for residual solvents that were separate to official recorded analyses.
The FDA said a full investigation of the site’s quality system is required to determine the extent of inaccuracies in data records.
It also suggested Zhejiang interviews “current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.”
In addition to the review, the FDA also wants Zhejiang to determine what impact the data failings have had on the quality of APIs made at the facility.
Response
Zhejiang – which is listed on the Shanghai Stock Exchange - makes ingredients for antibiotics, antidiabetic medicines and immunosuppressant drugs.
In a statement (here in Mandarin) the firm said it “will take this opportunity to pay close attention to quality management, and effectively improve the level of compliance.”
According to its 2015 annual report, Zhejiang makes vancomycin for Pfizer’s Hospira division.
A World Health Organization report from 2012 states that Zhejiang's vancomycin activities are based at the Xinchang facility
Pfizer told us: "Zhejiang, Medicine Co Ltd, China currently supplies Vancomycin API to Hospira, Inc., a Pfizer company.
"We have not seen any indication of any issues with the product. Pfizer’s Quality Management Program includes measures to ensure that all products meet Pfizer’s quality standards before they are released into the market."
Zhejiang did not respond to a request for comment.