Most drug manufacturers respond immediately to the FDA after having their plant operations criticized in an inspection. Not China’s Xiamen Origin Biotech. It hasn’t responded about the inspection at all.
Oh, the Fujian-based operator did contact the FDA about the fact that its API products had been put on an import alert list in May, but about the January inspection that led to its products being banned, and now to a warning letter from the FDA, the agency says it has not heard word one.
According to the warning letter that the FDA posted this week, Xiamen Origin Biotech has big problems. It has no written procedures for how to handle all of the basic requirements, supplier qualification, sampling, product release, training, labeling, or document retention. It was unable to produce one record for its labeling operations going back 18 months.
The company also tried to delay and mislead inspectors, the warning letter says, telling them there were no drugs at the facility even though there was clearly a warehouse at the site. Employees also denied the company was relabeling APIs any longer, the FDA said, despite evidence that it sold relabeled products throughout 2015 and into 2016.
On top of that, the company repeatedly falsified and omitted information on the certificates of analysis (CoA) sent to customers, the FDA said. It fabricated the name of an employee, then used the fake name as “the false signatory authority on the CoA,” the FDA said.
The warehouse was dirty and a rodent was seen in a room next to it.
The FDA suggested that Xiamen Origin get a consultant to learn how business is done with the U.S. It pointed out to owner Zhang Jian that the company can expect to remain on the FDA’s import alert list, and its products prohibited from coming into the U.S., until the company responds and fixes its issues.
The warning is one among a series sent to Chinese drug manufacturers in recent weeks, as the FDA steps up its oversight of a rapidly growing API exporter.
- here’s the warning letter