Employees of Chinese drugmaker Jiangsu Hengrui Pharmaceuticals “diverted” FDA inspectors as colleagues tore up and threw away documents in a “rapid-like manner” at a manufacturing facility, according to a newly-released Form 483.
At least one Hengrui employee called ahead “as soon as” the FDA requested access to the office waste area and then led inspectors down a long route. Documents torn up included validation protocols, reports and standard operating procedures. A paper stack around 8-inches was found near them.
The eight-page document outlined eight observations found by the FDA. The inspection was conducted between Jan. 8 and Jan. 16 of this year at the company’s facility in Jiangsu, China.
Other issues were found in the facility’s quality control unit. Drug products waiting to be thrown away were left unattended and with the building’s doors left open. Also, the 3.5-foot fence surrounding the facility did not effectively trigger an alarm to warn against trespassing.
The facility also had no program in place to review any of the site’s electronic data, the report says.
Further, machines were not properly sterilized, including equipment manufacturing injectable drug products for the US market, and not all operators working in commercial production seemed to be appropriately qualified, according to the form.
Other apparatuses were not cleaned, and storage systems did not provide adequate protection from the environment — both problems that can cause drug product contamination.
Hengrui has a pipeline of 13 in-house manufactured products available in China and over 80 in-house drugs in clinical trials, according to its website.