FDA slams Chinese API maker with warning letter on heels of issuing Form 483

Less than two weeks after posting a scathing Form 483 filing, the FDA slammed Chinese API maker Sichuan Deebio Pharmaceuticals with a warning letter (PDF) citing “significant deviations” in its manufacturing operations.

The regulatory agency’s chastisement dates back to a September inspection at the company’s facility, which is located in the city of Guanghan in the Sichuan province. That inspection uncovered issues of not keeping timely records, quality control oversight and other problems, according to the FDA.

Most notable was a Sichuan Deebio quality control team leader who misled inspectors about the results of a microbiology test.

“The investigation revealed that QC (quality control) personnel admitted to not having written down the test results and relying on their memory, indicating, ‘I haven't written it yet’ and ‘It's in my head,’” the FDA said.

Such non-contemporaneous documentation of lab records raised alarms with inspectors concerning the validity and integrity of the company’s records, the agency added.

The warning letter comes shortly after the FDA posted a Form 483 document (PDF) revealing several production shortfalls at the plant, including issues with records and quality control. Although Sichuan Deebio responded to the Form 483 and acknowledged the problems, its response was deemed inadequate by the FDA.

The company told the agency that it was committed to suspending production of an unnamed API destined for the U.S. market. The FDA, for its part, wants to know more about the company's intent to resume production of the drug for export to the U.S. in the future.

If the manufacturer wants to resume production of the API for the U.S. market, Sichuan Deebio was told it must notify the FDA.