This is not the first time FDA pay a visit to the plant. Probably, there were more than 5 visits during the past 10 years and none of them had so many violations as the recent one. Also how do you explain so many recalls doing the last 5 years? Clearly, the quality is going south during the last few years. Who should be responsible for the fall? The never ending waves of layoff had lowered workers' morale. It also forced out many experienced employees and created new incompetent "leader" who knows little of the daily operations and regulations.