Just days after the U.S. FDA joined the EMA and Health Canada in announcing a second impurity, called NDEA, has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals the FDA has released a third Form 483 to the company. Following inspections in July and August, the FDA issued the 483 with 11 observations, with perhaps not surprisingly specific issues raised about the firm’s quality unit. The FDA also found the firm’s change control system, designed to evaluate all changes that may affect production to be inadequate. Learn More