- Yangzhou Hengyuan Daily Chemical Plastic, a China-based manufacturer of finished pharmaceuticals and hotel amenities, including toothbrushes and toothpaste, recently got hit with a warning letter from the Food and Drug Administration detailing the company’s lack of oversight over the chemical makeup of its drugs.
- In one instance, the agency found a batch of drug product had none of its purported active ingredient. What’s more, a follow up investigation by the company found an incorrect ingredient had also been added to the batch.
- The FDA requested a master batch record of the company’s drug product, as well as a corrective plan addressing how the the firm would identify and fix the sources of the violations.
The FDA placed the company on Import Alert 66-40 on August 12, banning products from entering the U.S. Fifty-three other Chinese pharmaceutical companies are also blocked from exporting to the U.S.
The agency did not specify what kind of drug was in violation, and redacted the name product in its letter, dated September 26 but only recently posted to the FDA's website.
“During the inspection, you acknowledged that your firm did not test all batches of finished drug product prior to release,” the FDA wrote in its warning letter dated Sept. 26.
“For example, in 2015 you tested only five of the #(b)(4) batches shipped to the United States. We note you did not perform the active ingredient assay for batch #(b)(4) prior to release. FDA analysis showed this batch contained no active ingredient." (The letters and numbers refer to redacted information.)
The letter was one of four warnings from the Center for Drug Evaluation and Research released this week. The other companies hit are located throughout Europe, with headquarters in the U.K., Switzerland and the Netherlands. Their warning letters were all dated Sept. 29.