Be sure that your Medical Director sends the FDA a letter stating that you are withdrawing your registration/licensure because you are no longer doing anything that requires registration/licensure (irradiating product). They should reply to you. Keep that letter on file. If the inspector shows up again anyway, show them the letter (trying not to smile too broadly :tongue:). He/she may still insist on inspecting, but it probably won't be as intensive - hopefully. Technically the FDA can check you out at any time because you are holding a blood supply and transfusing patients, but they are so understaffed that they probably won't bother coming anymore if you are not having any problems that call attention to yourself. The final year of our FDA registration, we irradiated about 20 units of blood and drew approx 40 autologous units. Our last-straw inspector was an English major I swear:mad:! She knew nothing nothing nothing about science, much less Blood Banking. She was on the phone constantly to her supervisor and citing us for stuff we had been specifically told by our previous inspector ( who did have some knowledge of Blood Banking) to do. While she was still picking nits in our records, my Medical Director marched to the CEOs office and told him 'effective immediately' that we were drawing no more autos and irradiating no more blood. When he returned to the lab, he told the inspector the same thing. She immediately started telling us that we were doing a fine job, we shouldn't cut those services, she was in no way implying that there were any large problems at our facility, etc, etc. The Medical Director stuck to his guns, though we did give the medical staff 30 days before we actually cut the cord. When our inspection report finally came from that inspector, you couldn't recognize our facility in it. She had more than half of the information wrong. Even though we withdrew our registration, we got a visit the following year. We showed the man the FDA response to our letter. He blustered a bit, did a cursory inspection because "you still have blood don't you" and left. We never saw a report from that visit and we have never been visited again. The same inspector showed up at the Red Cross depot near us outside of the normal inspection process and several other facilities in our area complained about his behavior and he got fired. So, a complaint might be worth filing.