The US regulator detailed its concerns about the facility in Chongqing, China in a letter published this week, explaining that inspectors who visited last May found evidence that unfavourable data had been deleted.
The agency highlighted Chongqing’s practice of conducting extra tests and discarding certain results as a concern.
“Your analyst told our investigator that it is laboratory practice to perform more injections than are required by the procedure, and then delete any undesirable result to ensure passing system suitability results.”
The FDA also said that rather than investigate out of spec data, the firm had retested samples until acceptable results were achieved.
The agency said Chongqing must conduct a comprehensive investigation into the extent of the inaccuracies in data records and reporting and gave the firm 15 days to respond.
Chongqing, which is a subsidiary of Shanghai Fosun Pharmaceutical Co. Ltd, makes active pharmaceutical ingredients (APIs) for treatments for a wide range of diseases, primarily for the Chinese market.
It also provides laboratory services, including analytical chemistry, preclinical pharmacology, toxicology, PK, BA, and BE services, as well as clinical trial services.
Fosun response
A Fosun spokeswoman told us the plant "is an intermediary trial production base for APIs and medicinal intermediates."
The ingredients made at the site - iron sucrose, pemetrexed and abiraterone - are at the registration stage and none have been listed for commercial sale in the US.
She also said: "The production base involved in the warning letter will be relocated and closed soon and the production of which will be transferred to a new base. Fosun Pharma pays high attention to quality and safety of its drugs.
"We have formulated a detailed plan and carefully promoted the relevant rectification of Chongqing Pharmaceutical Research Institute accordingly. We will also actively communicate with FDA in order to complete such rectification as soon as possible."
Fosun told the investors the warning letter will not have material impact on overall performance.