Chinese drugmaker Shanghai Fosun Pharmaceutical (Group) Co. Ltd. said the Chongqing Food and Drug Administration made an unannounced inspection at the research institute of one of its subsidiaries on Aug. 23.
The inspection was prompted by whistleblowers who wrote a letter to the regulator alleging violations in the manufacturing practices of Chongqing Pharmaceutical Research Institute Co. Ltd., Reuters reported on Aug. 31. The news caused Shanghai Fosun's stock to drop by as much as 10% that day.
Certain employees of Chongqing Research Institute alleged that not all of the company's manufacturing was in accordance with approved processes and that the company fabricated its records.
Fosun said the Chongqing FDA has not reached any conclusion and the company is awaiting a response from the regulator following the inspection.
"All existing products are manufactured in accordance with approved production process. At production stage, adjustments to the production process have been approved by or filed with the relevant drug regulatory authorities," the company clarified in a statement.
The company is monitoring the situation and plans to update the market once it receives a response from the regulator.