Shandong Boyuan Pharmaceutical Co., Ltd.

The FDA this week posted an untitled letter sent Oct. 17 to China-based active pharmaceutical ingredient (API) manufacturer Shandong Boyuan Pharmaceutical Co., whose exports to the US have been blocked by the regulator. The agency said in the letter that the API manufacturer, which on its website says it works with Indian generic drugmakers like Dr. Reddy’s and Cipla, will remain on the US government’s list of blocked imports until the manufacturing facility can verify that it’s compliant with current good manufacturing practices. Shandong Boyuan was added to the FDA’s list of blocked imports in July. Letters like the one released this week reveal the cause of those actions. “During a teleconference meeting held with your firm on September 12, 2024, you were informed that your API were previously imported with an intended use for human pharmacy compounding. Before distribution to the U.S. market, you need to correct the CGMP deficiencies,” the FDA said in the letter. While such communications are usually warning letters and the result of onsite inspections at manufacturing facilities, this one says it’s based on a remote review of the manufacturer’s records. The review found that the company didn’t validate its manufacturing processes for a drug, the name of which is redacted. The FDA also cited the company for not performing stability studies and for not validating its analytical test methods. “There is no assurance that the methods you use are able to adequately assess the quality attributes of the API you manufacture,” the FDA said.