- The Food and Drug Administration has issued a warning letter to Chinese drugmaker Yicheng Chemical Corp. for quality control issues that the agency cautioned could lead to "life-threatening allergic reactions."
- At Yicheng's facility in the city of Changzhou, FDA inspectors noticed the company wasn't keeping production separated for the different drug products it manufactured, often using the same equipment to weigh and package the products.
- Additionally, the agency cited Yicheng for poor documentation practices. Yicheng also didn't have the necessary protocols in place to track its APIs as they traveled through distribution channels to markets.
Yicheng's warning letter is one of the first issued in 2018, yet it illustrates a years-old issue of Asian drug developers violating good manufacturing practices.
The FDA doesn't take warning letters lightly, but its tone in each does vary depending on the severity of the company's violations.
In Yicheng's case, the agency was not at all impressed with the response letter it received after a July inspection of the drugmaker's manufacturing plant.
According to the warning letter, Yicheng outlined what it thought would be an adequate solution to the problems inspectors had noted. The company would continue developing multiple products in the same space, but set specific times for each to come through, be handled, labeled and packaged, then move on. The space would then be cleaned before bringing in the next drug.
Regulators, however, contended that such procedures would still leave the drugs created at Yicheng's plant vulnerable to contamination.
"Cleaning cannot substitute for proper segregation," the FDA wrote, adding that with certain products produced at the plant, cross-contamination "can initiate life-threatening allergic reactions or other drug-induced ... reactions."
"Your current practices demonstrate an unacceptably high risk of ... API cross-contamination into other API repackaged at your facility," the agency said.
The FDA recommended Yicheng hire a CGMP consultant to help get its production back in compliance. Regulators also suggested the company go back and determine if any cross-contamination occurred in the API packaged at the facility, though they emphasized that avoiding shared production spaces in the first place would be a much safer route to take.
As a result of Yicheng's inadequate initial response, the FDA placed the company on its import alert list last August.