Failure to control nonconforming products landed Dongguan Microview Medical a warning letter following an FDA inspection of its facility in Guangdong, China.
The firm failed to properly deal with disposable endoscopic cannulas that didn’t conform to specifications. FDA investigators found bins of finished devices and subassemblies that lacked product identification and acceptance status labels. When asked about the products, an employee identified them as nonconforming products.
The devices were initially placed in a sealed pouch and then placed in a shelf carton, but the firm failed to validate the packaging process after the sealing process was relocated.