- When in Doubt, Take the Investigator Hostage
Allegation
In July of 2017, an FDA investigator visited a facility in northeastern China where Zhejiang Bangli Medical Products manufactured lidocaine and capsaicin skin patches for treating pain.
According to internal emails reviewed by WIRED, soon after the investigator and her translator began their work, worried company officials started interrogating them and questioning their authority to inspect. After the firm’s general manager became visibly upset, the inspectors went to gather their things in the conference room. The GM refused to let them leave, effectively imprisoning them, and called the police, who, according to the FDA, claimed their credentials were fake. More than an hour later, after the intercession of Chinese drug regulators, the FDA employees were finally freed.
As FDA officials grappled with the incident, one deputy director wrote in an email to her colleagues, “It is our belief that [the general manager]quickly understood that the inspection was not going to go well and resorted to appalling intimidation tactics to try to get out of the inspection.” However, the agency declined to classify the incident as refusing an inspection—grounds for an automatic import ban—because it wasn’t clear whether the plant manager who’d imprisoned the investigators “was making a specified refusal,” one senior FDA official noted.
Outcome
In a follow-up inspection the next month, an investigator discovered that the plant was not actually testing any of its products or ingredients to ensure their purity or strength and didn’t have cleaning procedures for its manufacturing equipment. The plant was placed on an import alert, which meant that its products were banned from entering the United States. Zhejiang Bangli did not respond to requests for comment.