This is an interesting question. I think inspections are always stressful for the quality department. Even if Regulatory has put forth current procedures and regulations of certain products, it is ultimate upon Quality ‘s responsibility to ensure that adherence to those regulations was properly met. The perspective of failing regulations and being issued a 483 can put Quality on very stressed state of mind. Besides being a public embarrassment for the company, a 483 can have a negative effect on future projects that the company will submit to the FDA. The FDA scrutinized them very thoroughly due to their prior 483. So basically, with each inspection, the future of the company lies in the balance.