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FDA Inspector


Mary**

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An FDA inspector (in a military unifom) spent 3 very long days last week inspecting my Blood Bank. She was rude and disrespectful. She was a nurse and did not have much working knowledge of the field.

Some of the things she "sited "were anything "handwritten" even if it was initialed and dated, lack of a procedure on how to take the daily temperatures even though the ranges were on the log sheet, a freezer alarm high set point was -20 C and the freezer alarmed at -19.9 and I could go on and on. She wanted copies of everything she didin't like. She even wanted copies of entire maufacturers equipment manuals.

The only reason we get inspected by the FDA is that our radiation oncology departemnt irradiates about 12 units a year for us. She spent about 20 minutes in oncology (out of 3 days) and did not site a single "Crossout", etc. I plan to have our Blood Center do our irradiation in the future and therefore to avoid this abuse.

I have never had a single CAP citation. Everything she tediously looked at and lectured me about repeatedly.

Large hospitals in my area and our Blood Center have also experienced the same issues recently, but we all had different inspectors. This was some consolation to me. Are they trained to act in such an unprofessional manner or what?

I guess I am done venting!!!:bonk::bonk::bonk:

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You can always contact the area FDA district and discuss your feelings about the inspection with the inspector's superiors . . . it would be better if you Medical Director did this. Some FDA inspectors are "out of control" and others are really intelligent and try to help you be better. I've seen them stay at a place and manually do the calculations for all donor testing for the past year because 1 unit of 2000 was only documented as destroyed in 3 out of 4 places/the facility's SOP. This is harassament, but - I was glad it wasn't my place.

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The ones that I have dealt with in the past were not quite as rude, but equally as misinformed about Blood Bank. Amazing to me that they don't have to be Clinical Laboratory Technologists...Sorry, sounds like you had a very stressful experience...I agree with David, have your Medical Director file a complaint.

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I worked in a place that had such a rude inspector that I think the Medical Staff director was going to file a complaint. She was so loud in during the outbrief that a meeting down the hall could hear her.

She also wanted copies of everything. She was a school teacher so you know she didn't know a thing about Blood Banking.

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Oh, Mary ....You have my sympathy!!!

I thought one of my FDA inspectors was "over-the-top" a few years ago, but yours goes far beyond! Where is the written regulation that says nothing can be handwritten? (Never heard of that one before!) And I have great sympathy for you if your staff needs written instructions on how to read a thermometer. (I wonder if the inspector, who was a nurse, felt like she needed the instructions?)

David Saikin gave a good suggestion about calling the district head, but you will probably want to just go ahead and smile and nod your head obediently and do what you need to do to address the citations, etc., to wrap up this unpleasant episode.

The FDA usually doesn't pay any attention to facilities unless they are registered or licensed by the FDA. However, I am under the impression that FDA can walk in at any time to any establishment dealing with donor blood and subject them to inspection, even if they do not collect or modify/irradiate donor blood. If that is true, you might not be "out of the woods" if you stop irradiating products. (Does anyone else have experience or know more about this?)

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An FDA inspector (in a military unifom) spent 3 very long days last week inspecting my Blood Bank. She was rude and disrespectful. She was a nurse and did not have much working knowledge of the field.

Do you know what her rank was? Maybe she was on TDY duty & just waiting out her time til retirement. What part of the country?

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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.

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Ann -

Thanks for sharing that with us. I don't know who your Medical Director is, but I know that I like him!!! (I bet it took you a long time to stop crying about dropping your autologous collections, right?)

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I had a 3 day onsite visit by the FDA about 7 months ago and she could not have been any nicer. Your Medical Director should speak with someone in authority at the regional office where this inspector works.

I'd also mention her rude and disrespectful behavior, she was there to perform an inspection and that's unprofessional.

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We haven't been inspected in a while (dropped autologous collections several years ago), but our inspectors (one since retired) were always pleasant & knowledgable. Maybe we had the same inspectors as Likewine99?

I also know that they will visit any hospital that transfuses blood at any time, if they so desire.

Linda Frederick

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We had a mixture before 'THE LAST STRAW'. Most of them were very professional, the majority of them were knowledgible, a few of them were very helpful to us and, unfortunately, a notable few were anything but knowledgable and helpful. I do believe that a complaint is important when an inspector is not doing their job professionally and with good knowledge of Blood Bank. The inspection process won't work if we can't interact in a positive way with the inspectors and FDA management has to know that. As a side note...in phone and email contacts with various individuals, I've gotten nothing but cordial, professional assistance.

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My last several FDA inspections have been smooth and uneventful. I have had a few pips in my time, but after reading all of this I believe I have been VERY lucky with the inspectors we have drawn. I hope our luck continues to hold...

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Experience or working knowledge is not a prerequisite for FDA. I interviewed with them for a top starting salary of 35K. I have many years expereince in cell therapy but I was going to start in food inspections. What can I say, go USA.

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Experience or working knowledge is not a prerequisite for FDA. I interviewed with them for a top starting salary of 35K. I have many years expereince in cell therapy but I was going to start in food inspections. What can I say, go USA.

It isn't for the MHRA either. Almost all of them come from the pharmasuitcal industry.

WIth the CPA, it is slightly better, in that they tend to be Biomedical/Clinical Scientists or Consultants, but, they don't necessarily have had to have worked in Blood Transfusion or even Haematology.

:mad::mad::mad:

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It isn't for the MHRA either. Almost all of them come from the pharmasuitcal industry.

WIth the CPA, it is slightly better, in that they tend to be Biomedical/Clinical Scientists or Consultants, but, they don't necessarily have had to have worked in Blood Transfusion or even Haematology.

:mad::mad::mad:

However, CPA inspections in the past were nowhere to the level of the MHRA inspections. Hopefully these will now improve with UKAS being involved and the new standards ( which are really the same as ISO 15189 ) used.

It should't really matter the specific background of the inspector, quality systems are the same, regardless of lab, industry ( just different levels).

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True, it shouldn't really matter, but when the inspector demonstrates that they do not have even rudimentary knowledge of what the laboratory does, but still insists on changes being made to fundamental processes, with no demonstrable improvement (and change should only be made if it can be measured), it most certainly does matter.

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We had an FDA inspector come in 30 yrs ago after we had shipped AB positive whole blood that expired that night to another hospital. They refused to swap patient to AB negative or A positive. We obtained an emergency release from them. Anyway they were reported for using expired blood and we were inspected for shipping them the blood. One of the Techs was planning something at church and had a bible in BB. The inspector saw the bible and said that she doesn't trust a BB that needed a bible to crossmatch by. She had her little 007 spy camera and took pictures of our logs and equipment and personnel. It wasn't pretty. Sounds like things haven't changed.

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I have been in blood banking since 1985 and I have always noticed that the FDA inspectors for Transfusion Services have no corellation at all with our field (nurses, food inspectors, etc). I have worked at a blood center and the FDA inspectors seemed to have knowledge of the processes. I see no difference between the two and I guess this is just a fact of life. I would contact the FDA--you can always protest with proper documentation.

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One of our hospitals actually had an inspector who is a blood banker.

Any transfusion service can be inspected at any time. It does not matter if you are registered, licensed, or not. There is a memorandum of record between FDA and CMS. They also must inspect you if someone files a complaint.

The uniform probably meant she is the other uniformed service - public health. http://www.usphs.gov/aboutus/questions.aspx#whatis

"Commissioned Corps officers from all professions are assigned to the FDA and serve in various capacities to advance the agency's mission. "

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