Whistleblower alleges API production fraud at Fosun Pharma

03-Sep-2018 - Last updated on 03-Sep-2018 at 12:22 GMT

(Image: Getty/Marchmeena29)

Chongqing FDA has published an open letter, apparently from an employee of Fosun Pharma, stating that the firm has fabricated a “large number” of production reports.

The full letter to Chongqing Food and Drug Administration (FDA) was published on the municipal regulator’s website (link in Mandarin).

According to the letter, the whistleblower could be multiple people currently working for the company and it states they were motivated by the recent vaccine scandal that generated widespread media coverage.

The allegations levelled at the company are particularly serious, with one line stating that “leadership led the staff to fabricate a large number of production records” and another reads that the company had “been very confused in production quality management”.

The particular drugs that were highlighted as having production issues were iron sucrose, aripiprazole, and pemetrexed disodium.

Aripiprazole is an antipsychotic drug and Fosun Pharma is one of the major manufacturers of the drug for both domestic and international markets.

In reaction to the claims made in the open letter, Fosun stated it had carried out an internal investigation. It noted that it “places great emphasis on the quality and risk management throughout the life cycle of its products. Therefore, [it] has adopted and implemented quality and safety control mechanisms and adverse drug reaction monitoring mechanisms at each stage of the production chain from R&D to sales of products, so as to ensure the R&D, production, sales, pulling off shelf and recall of products are conducted safely and properly”.

Fosun concluded that it would “closely monitor the developments of the event as mentioned in the letter, and will comply with its disclosure obligation”.

The Chongqing FDA announced in reply to the letter on its website that it had already started to carry out an investigation in relation to the allegations. The agency noted that it had not yet found any illegal violations.

In addition, it revealed that it had tried to contact the whistleblower but they had left false details and so were unable to reach them.

The company has had previous trouble with the US Food and Drug Administration, with the agency taking issue with the deletion of unfavourable production data.