The FDA has slapped a warning letter on a Chinese drug manufacturer that shipped multiple lots of an OTC product to the U.S. containing the wrong API because the company messed up a translation.
A warning letter was issued Oct. 30 to OTC drugmaker Guangdong Zhanjiang Jimin Pharmaceutical laying out a host of issues, including discovering that it was using the wrong API for an anti-itch product that was labeled as containing hydrocortisone.
“Our investigators reviewed records showing that the active pharmaceutical ingredient (API) actually used in this product was dexamethasone acetate—a different API,” the warning letter said. “When our investigator inquired about the incorrect API, your firm stated that there was a translation mistake, and the two APIs were believed to be the same ingredient. Your quality unit approved multiple lots of this drug product for distribution to the United States containing the incorrect active ingredient.”
The FDA says the company in August did recall the products but never provided any details on its investigation into how the mistake occurred and what it would do to prevent the same issue from occurring in the future. On top of that, the FDA told Jimin Pharmaceutical its Piyanping Anti-Itch Lotion is not an approved product.
The company also was not adequately testing for microbial contamination and wasn’t testing all of its batches for strength and the identity of the APIs in them.
The FDA added the Chinese company to the import alert list in August and has recommended it hire a consultant to help it figure out FDA regulations if it intends to sell products in the U.S. at a later date.