FDA Inspector

[tricore]

The first part of my post got lost.

Please notify your district office if you feel the inspector was rude and unprofessional. Our district office takes complaints like that very seriously.

[Mary**]

Thanks for the link.

[Brenda K Hutson]

With 26 years and 6 Insitutions (having been the point person for many Inspections), here is the worst Inspection I ever had (AABB, FDA, CAP, JCAHO, Sate Dept. of Health Services).

I was in charge of a Blood Bank at another Hospital 8 years ago. We were subjected to FDA Inspections because we had a cellwasher (after this Inspection, we stopped washing blood)!

The Inspector that came was a Nurse (as for you). We were her 1st Inspection. At the last minute (before she was ready to end the Inspection), she found something (don't you just hate it when that happens ). This caused her to dig deeper. Because she was inexperienced, she kept calling a nearby collegue. After a week of this, the next Monday, she came back with her "nightmare" supervisor, and they re-started the whole Inspection!

This supervisor was by far the rudest, most unprofessional person I have come across in my career! She always talked down to me. When she would bring up an issue, if I tried to discuss it with her from a technical perspective, I would get a "look" that said; I don't want to hear any of your "excuses; " you are just trying to get out of being cited. My "explanations" were valid; I was not trying to get out of anything; just trying to explain some things. Though she was rude in many ways at all times, this is by far the worst episode: our platelet rotator was out at room temp. for a few days at one point because the incubator had to be repaired. We did take manual temps. every 4 hours. It was a challenge to maintain the temperature in that the temperature of our dept. fluctuated at times. We did work with Facilities when that happened. There were some issues around the documentation of the whole event and the Inspectors also spoke with Facilities. Toward the end of the Inspection, I received a call from the Inspectors in my office (they refused to let me stay in the conference room where they were reviewing records). They asked me (actually, ordered me) to tell the Director of Facilities that they wanted him at the closing meeting. So, I called him and relayed the information. He said he could not stay; that he had committment XYZ. I told him that "he" needed to go tell them that, not me. A few minutes later, I recieved a call from one of the Inspectors, asking me to come to the conference room. When I got there, the guy from Facilities was standing there. The rude FDA supervisor shockingly said to me: Ms. Hutson, did you try to talk Facilities into not coming to the closing meeting?! I...was...in...shock!:mad:

I said, NO; you told me to ask him to come and I did; he said he couldn't so I told him he needed to relay that! Both he and I just stood there with our mouths hanging open.

I immdiately went to my Medical Director and told him what happened; I said "this is no Inspection; this is harrassment!" He agreed but said that if we made a big deal of it, it might be worse next time (so retaliation).

I don't care if they are government employees; that does not give them the right to come into our Labs (where we all strive to do the best we can) and harrass us and question our integrity like that. They should have to be accountable; just like we all are.

Oh, and one other thing that comes to mind. Some months prior to that Inspection, I had been told by my donor facility that a local reputable Hosptial had been cited for XYZ by the FDA. The Manager there almost quit, because XYZ is not a requirement by any regulatory agency (still isn't). He cited them anyway. Because I was told about this, I made a Log to start documenting XYZ. When this Nurse Inspector came, sure enough, she asked to see my documentation. I did comment to her that the only reason I had started doing it was because I heard that this other Inspector had cited a local Hospital. She replied, "oh yeh, that is "his thing," Since when can FDA Inspectors walk into Hosptials and start making their own rules/regulations on the spot; and on top of that, citing you if you aren't doing it?? If there is an issue that an FDA Inspector feel strongly about (it is "their" thing), then they should bring it before the FDA regulatory committe and decide if they should add it to the CFR. Until then, we are all at risk of being cited for something we aren't doing, because we don't know what our Inspector will have a "thing" for; we cannot possibly be prepared for that. But they do get away with it because they work for the government, and because no one wants to make waives and risk being shutdown.

The FDA Inspectors should be held accountable just as others are. I am willing to be Inspected and "take my citations like a grown-up;" I am NOT however, willing to have someone come in and treat me like I am totally incompetent, harrass me and treat me with rudeness. Is there any way to anonymously report an Inspector??

I think I still have post traumatic stress from that Inspection!

Brenda Hutson, CLS(ASCP)SBB

[Kellpos]

Wow, that took a lot just to get through. It sounds like you had no support. Why wasn't your medical director there at the meeting? Also, where was administration? Inspectors always drop by their office first to let the hospital know they are there (because they feel so important).

I would love to see your post make its way to the FDA regional office. Better yet, HHS.gov

[Brenda K Hutson]

Wow, that took a lot just to get through. It sounds like you had no support. Why wasn't your medical director there at the meeting? Also, where was administration? Inspectors always drop by their office first to let the hospital know they are there (because they feel so important).

I would love to see your post make its way to the FDA regional office. Better yet, HHS.gov

The Medical Director was at the closing meeting, and as I said, I did make him aware of what was going on. I know he believed me, but given that experience, perhaps he was correct in thinking we would be best not to get them more upset by reporting it. The upper Management was aware of what was going on, but again, I think we all of this fear put in us of the FDA because we know they have the power to shut us down; and this woman was just mean enough to do it too! And clearly that is how others react given that the Lab Manager at the other Hospital that was cited for something that was a "thing" to that Inspector, almost left because her boss wrote her up for arguing with the FDA Inspector! The Inspector showed this horrible side at our closing meeting and I am grateful for one thing: The Lab Director (Management, not Medical Director) and the Pathologist over my dept. (not the head that I had gone to), both approached this FDA supervisor after the closing meeting and said, "you know, it would have been nice if you had also taken the time to mention all of the "good" things about the dept." They got that "look."

I should have said in my initial thread that I know that not all FDA Inspectors are like that. The one in the region where I live now, though tough at times, is fair and treats people with the respect and dignity that she expects. And when I think about careers of "power," I suspect they attract 2 types of people: those that chose it for the right reasons, and those with control issues who abuse that power. Well, we know which category "that" Inspector falls into.

I appreciate your support but in all honesty, with your last comment, I have to admit that I was afraid to even post my experience.

Brenda Hutson, CLS(ASCP)SBB

[Malcolm Needs ☆]

I know exactly how you feel Brenda.

We had an MHRA inspector that was the male mirror image of your female FDA inspector.

[Brenda K Hutson]

Well, being new to this website, I think I just learned something. I had quite a few FDA e-mails in my inbox today. I assumed that they would be on this site so I deleted them without reading and logged onto this website. Hmm...I guess you can send e-mails just to the person vs. the site.

So, I would LOVE to read what you all had to say; if you would not mind sending the e-mails to me again.

Sorry, and thanks...

Brenda Hutson, CLS(ASCP)SBB

[Mary**]

:cries:You have my complete sympathy! I know what you mean about retaliation.

I asked my inspector why the FDA didn't have a check list like CAP does. She said she would love to have one. I have been in the field for 35 years and they all still arrive with those light green, hard bound notebooks that have blank pages. They can write anything they like on those blank pages!

She also said that she didn't think much about the CAP and that I needed to reference the CFR in my procedures.

[RR1]

May be we could encourage your FDA guys to liase with our MHRA guys. There is soon going to be an inspection checklist produced to standardise the european inspections for compliance to the blood directive 2002/98/EC.

[tricore]

FDA did use a checklist pre 1994. I used to have a copy. You may find these links helpful. I have also found that if they find something wrong at a site they will look for the same thing at the next sites they inspect. Example: they found some sites they inspected (not necessarily blood banks) that were not changing the times on their irradiators to compensate for source decay.

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/CompliancePrograms/ucm095226.htm

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074183.htm

[Brenda K Hutson]

FDA did use a checklist pre 1994. I used to have a copy. You may find these links helpful. I have also found that if they find something wrong at a site they will look for the same thing at the next sites they inspect. Example: they found some sites they inspected (not necessarily blood banks) that were not changing the times on their irradiators to compensate for source decay.

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/CompliancePrograms/ucm095226.htm

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074183.htm

Well, that is ok as long as what they look for at the next site (because they found the problem with the previous site), is an actual regulation; not just "their thing;" the way they think things should be."

Brenda

[jcornell]

Our recent FDA inspection was also by an inspector who wore a Navy like uniform. Although I personally had little interaction with her in the 3 days she spent here, she seemed to be quite professional, thorough and even pleasant. I guess it's the luck of the draw.

[Malcolm Needs ☆]

For those of you who have read my posts on this page, you will know that we were inspected by an MHRA Inspector from hell.

I can now reveal that we have been inspected by the MHRA again last week. The inspector was extremely thorough and, of course, picked up the odd minor non-conformance, but he was pragmatic where necessary, he listened, he was pleasant, but firm and he had a sense of humour.

This just goes to prove that a) not all inspectors are the same and that it is quite possible to be firm and thorough, without being arrogant and dogmatic.

Why the first inspector thought this was necessary, or part of his job is way beyond me.

:eek:

[Mary**]

I am glad you had:clap: a positive experience. What does MHRA stand for?

[Malcolm Needs ☆]

I am glad you had:clap: a positive experience. What does MHRA stand for?

Medicines and Healthcare Products Regulatory Agency (that's the polite version anyway)!

Thanks Mary.

:):)

[Sheila]

An FDA inspector showed up at lunchtime last Friday. He was not the inspector we have had for the past several times. He was very professional and courteous, and stayed about five hours. This facility does no irradiation, washing, etc.; we are strictly a transfusion service and do no product modifications except thawing frozen products.

I must have xeroxed 50 different forms, procedures, certificates, etc. The dude was definitely fond of paper. He even wanted copies of position descriptions, and wanted to see employee performance appraisals.

He had a question I've never been asked before by any inspector. He wanted to know if the building was treated by exterminators for elimination of pests, and if so, was it done in house or contracted, and if contracted, the name and address of the company. ??? This is relevant HOW?

At any rate, I'll find out how we did after the FDA sends a letter to the hospital director.

[SMW]

See the 200 series of the CFR for the regs concerning infestation and procedures for use of rodendticides, insecticides, etc. and applicability to work performed by contractors and/or in house staff. Personnel qualificiations and responsiblities are also in this series.

Just curious, if you are only a transfusion service (not collecting any donors) and not performing manufacturing other than thawing plasma products (which does not require registration), do you know why you are even being visited by the FDA?

[Lekota40]

I work at a blood center and we have FDA inspections. We handwrite way more documentation than anyone wants to and passed with flying colors so not understanding the "no handwriting" item.

[tricore]

An FDA inspector showed up at lunchtime last Friday. He was not the inspector we have had for the past several times. He was very professional and courteous, and stayed about five hours. This facility does no irradiation, washing, etc.; we are strictly a transfusion service and do no product modifications except thawing frozen products.

I must have xeroxed 50 different forms, procedures, certificates, etc. The dude was definitely fond of paper. He even wanted copies of position descriptions, and wanted to see employee performance appraisals.

He had a question I've never been asked before by any inspector. He wanted to know if the building was treated by exterminators for elimination of pests, and if so, was it done in house or contracted, and if contracted, the name and address of the company. ??? This is relevant HOW?

At any rate, I'll find out how we did after the FDA sends a letter to the hospital director.

Why are you expecting a letter? Did the inspector leave a 483 with citations?

[L106]

Why are you expecting a letter? Did the inspector leave a 483 with citations?

We always receive a letter from FDA after an inspection (usually one or two months later), regardless of whether any violations were cited.

[SMW]

,,,makes we wonder if the facilities that are reporting receiving a letter from the FDA sometime after the "inspection" rather than at the closing are VA facilities that the FDA is required to visit even if the facility does not perfrom any activities requring FDA registration.....??

[L106]

,,,makes we wonder if the facilities that are reporting receiving a letter from the FDA sometime after the "inspection" rather than at the closing are VA facilities that the FDA is required to visit even if the facility does not perfrom any activities requring FDA registration.....??

No, we are not a VA facility. (Just a regular not-for-profit hospital.) I suspect that the timing of the letter stating the inspection results depends on the inspector's way of doing things (but I could be wrong.) Even when we have had no violations cited, I think there are usually a couple issues that our inspector is unsure about until she goes home and does some research in the CFR (ie: the "book of rules", for our non-American BBtalkers.)

[Sheila]

Yes, we are a VA facility and thus have always been FDA inspected. However, the University hospital across the street has frequently been FDA inspected as well, perhaps due the misfortune of being located so close to a VA!

There is a major blood center just a few blocks away too, and another major hospital in the near vicinity. I think the FDA stays for the week and "makes the rounds". I was warned early last week that the FDA had been at University.

We have also always received a letter in the mail at a later date. I believe the inspector goes back home and does some research, then sends the letter, because there have been a couple of times that the letter mentioned items not mentioned during the inspection itself.

Edited August 18, 2009 by Sheila

[hunb]

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

I 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?)

In my limited experience with FDA inspections, one in eight years, they are quite meticulous in inspecting logs and procedures. My inspection was unannounced and we are a non-licensed transfusion service. Day one I was off work and my counterpart in Blood Bank gave the inspector all the manuals and insight needed, Day 2 I was present and walked her through our SOP's and documentation. She did not have any background in laboratory and seemed confused by the simple things that we were doing as a transfusion service. She was somewhat rude but overall did a good job, we were written a recommendation on correction of clerical errors. One of my tech's was fond of white-out and was making corrections in our disposition log with it.

[mallen5usa]

Did the inspector issue a Form 482 (Notice of Inspection)? If not, then you weren't really "inspected". They do have the authority to walk into any place dealing with regulated products, but not necessarily to inspect. Since there was a specific request for performance reviews, and the odd ball question about exterminators, they may have been following up on a "whistle blower" type report that had to do with a related situation?

m