When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. Unfortunately for Jiangsu Hengrui Pharmaceuticals, the company’s refusal to do so has resulted in a scathing production write-up from the U.S. regulator.
In an eight-observation Form 483, the FDA chided Hengrui for a laundry list of manufacturing missteps including poor contamination controls, subpar cleaning protocols and failure to promptly hand over documentation to inspectors.
The FDA carried out its inspection at Hengrui’s site in the city of Lianyungang in China’s Jiangsu province between Jan. 8 and Jan. 16. The regulator publicly posted the manufacturing citation on its website earlier this week.
News of Hengrui’s Form 483 comes shortly after the company and Elevar Therapeutics were slapped with rejections on their respective applications for PD-1 inhibitor camrelizumab and the VEGFR inhibitor rivoceranib. The pair had been hoping for a combination approval in first-line liver cancer. That said, the Form 483 is not related to the FDA’s approval snub, Hengrui told Fierce Pharma over email.
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.
As for other quality control oversights, the FDA noted that injectable drug products queued for destruction in Hengrui’s waste area were not secure.
Hengrui also faced agency criticism for failing to establish adequate sterilization processes to prevent microbiological contamination and failing to control against environmental contamination.
During the agency’s walk-through, FDA investigators noticed a large pool of water on the floor of a warehouse where pallets of released finished injectable drugs were stored, as well as a “black mold like growth” on the floor below and around an air condenser.
Hengrui isn’t the only manufacturer that's attempted to destroy evidence, according to FDA records.
Last summer, India’s Intas Pharmaceuticals received a five-observation warning letter from the FDA after the regulator turned up plastic bags filled with torn and discarded manufacturing documents under a stairwell and on a truck outside the facility.
To make matters worse, FDA staffers caught an Intas analyst destroying manufacturing records by dousing them in acetic acid inside a trash bin.
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