Chief among Hengrui’s slights, the company failed to make production records readily available for FDA inspectors, according to the agency.

In the Form 483 document, FDA staff said they were led down a longer route to stall their arrival at the location where Hengrui discarded office waste. Once the party reached the waste bins, the FDA staffers saw an employee “in a rapid-like manner placing documents in the waste bin,” while other individuals watched her—one of whom appeared to have torn documents in hand.

The FDA outlined the contents of those documents in a separate observation, noting that discarded batch records, validation reports and change controls did not always match archived official records.

This attempt at obfuscation by Hengrui ultimately delayed the FDA’s inspection, according to the manufacturing write-up.