Fool me thrice: FDA blasts Chinese API maker for 'misleading' investigators, making up testing records

When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by fibbing about the existence of testing logs ranks high on the list.

Now, China’s Sichuan Deebio Pharmaceutical is learning that lesson the hard way in the aftermath of a U.S. regulatory inspection carried out in September.

In a Form 483 recently made public, the FDA chided Sichuan Deebio for multiple serious manufacturing and quality lapses at its active pharmaceutical ingredient (API) facility in the Chinese city of Guanghan in the Sichuan province.

Timely record-keeping, quality control oversight and written procedures and more proved points of contention for FDA investigators, who ran their inspection of Sichuan Deebio’s plant from Sept. 4-8, 2023.

The FDA’s first observation in its manufacturing write-up is perhaps the most damning, centering on the company’s failure to complete lab records in a thorough, consistent and timely manner.

The Form 483 relays an especially troubling event during the inspection when Sichuan Deebio’s quality control team leader provided “misleading information” about records on the results of a microbiology test.

At first, the quality control chief lied about viewing those test results, logging them and leaving them with another team member on a different floor of the facility, the FDA contends in its report. Then she changed tack, claiming she had not read the results, before switching back to a story similar to her first. At last, the QC chief “finally” admitted that she was “not telling the truth about recording the results on respective data worksheets, and no worksheet existed,” investigators wrote in the Form 483.

To make matters worse, investigators subsequently asked the quality leader how she kept track of the test results, to which she replied that they were “in her ‘mind.’”

Beyond that infraction, the FDA claimed Sichuan Deebio’s quality control unit “lacks responsibility” to approve procedures, specifications or test methods that weigh on the strength and purity of drug substance. Investigators specifically harangued Sichuan Deebio for poor supervisory oversight of laboratory electronic systems and data.

The company also dropped the ball when it comes to writing up established procedures for production and process controls for consistent drugmaking, the FDA said. Further, Sichuan Deebio’s investigation archives for batch failures or discrepancies “do not always include the conclusions and follow-up,” the regulator added.

Codified procedures for equipment maintenance and cleaning were subpar as well, the FDA wrote in its Form 483.

Lastly, Sichuan Deebio failed to implement control procedures to validate manufacturing processes tied to potential variability of the drug substance the company cranks out.

While still less than two months into to 2024, the FDA has already been busy dishing out manufacturing reprimands at a steady pace.

In early January, the FDA unleashed a salvo of 483s aimed at Indian drugmakers Dr. Reddy’s, Laurus Synthesis and Torrent Pharmaceuticals, rebuking the companies for problems not limited to record-keeping, employee training, quality lapses and poor equipment hygiene.

Later that same month, biosimilar developer Alvotech received yet another Form 483 at its facility in Reykjavik, Iceland. Still, the company was quick to parry with its belief that the “observation is readily addressable,” Alvotech’s CEO Robert Wessman said in a press release last month.

Toward the end of January, Aurobindo subsidiary Eugia U.S. received its own production reprimand with a whopping 10 observations at its facility in New Jersey. Among other problems, investigators turned up a damaged HVAC system near a classified aseptic processing line, plus what “appeared to be damage caused by ceiling leaks” next to Eugia’s aseptic processing area.