By Jim Dickinson

FDA has cited South Korea-based ChungDo Pharm for QSR violations after a March inspection documented several manufacturing problems with the firm’s Chemview-10 Urinalysis Test Strips and Chemview-11.

A recent warning letter says ChungDo failed to establish and maintain procedures for implementing corrective and preventive action (CAPA) and to document all related activities. For example, it says, the firm failed to investigate the cause and document an investigation involving an oral complaint on the quantity of Nitrite 10T shipped with its Chemview-10 device.

Additionally, FDA’s letter said the firm failed to establish and maintain procedures for validating the device design. For example, it failed to establish a stability validation protocol/ procedure for both Chemview-10 and Chemview-11. And, it also failed to validate the long term stability claim for the 24 month lifespan specification for the Chemview-11 device.