Anyone hear about this? FDA might pull manufacturing license.

http://www.boston.com/business/healthcare/articles/2009/06/26/immucor_fda_could_pull_manufacturing_license/

Just read the NOIR letter. I was actually notified by another reagent vendor.

more info in attached

09-0625Immucornoticetorevoke.pdf

Interesting....might explain a few problems I had !!

Yes, I heard about it from another company that is trying to then get me to purchase the reagents from them that I have been purchasing from Immucor (which is pretty tacky if you ask me:rolleyes:). The e-mailed me today discussing their products, and then the "reason" they were telling me about their products. They even attached a copy of the FDA letter to Immucor.

Brenda Hutson, CLS(ASCP)SBB

Not surprised; company has been without a QC mgr for almost a year, and now I see that they are minus a QC director as well.

This was in a blurb from AABB yesterday. I can't see the feds pulling their license - they will probably end up like Abbott (having the feds approve all their lot releases).

:cries:If the FDA goes through with it, those of us who use Immucor products, especially red cell products could end up without any reagents!

That's why they won't pull their license . . . they will just make their life miserable. Be prepared for some delays with lot releases though (this is what happened to Abbott).

And Immucor tells us that they are expecting to spend 6 or 7 million dollars for a Quality Improvement Project to correct the issues with the FDA. Translation = reagent costs will skyrocket again. Ugh

The Immucor letter sounds just like the blurbs from Abbott - state of the art QA program, best in the business - blah blah blah . . . BS!

And those of us using Ortho reagents will probably be held hostage too.

You know, we're have such better quality than the other guys and you should be lucky to have us as your vendor, blah blah blah $$$$$

Do we really want reagents from a company that hasen't addressed issues from a 483 issued in January 2008 and a warning letter issued 5/2/2008? From January to December 2008, approximately 2398 Reagent Red Cell product complaints were received. That is a lot of complaints about a product not in use by the general population. I would expect that FDA wouldn't yank their license unless they make sure other manufacturers can take up the slack. I tend to agree with David that FDA will have to approve all lot releases. More of a problem with the red cell products because of shorter shelf life.

Just curious......How do you happen to know that 2398 Reagent Red Cell product complaints were received? (Again, just curious.)

See item #6 of the FDA notice of intent to revoke license

Warning letter from May 2008

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048317.htm

One does wonder with the astronomical price increases where all the money went to. Quality Control/QA?

Having notified Immucor several times of problems with red cells, there was always the Technical Services response that there have been no other reports of problems. From what the FDA found who knows how many other reports of problems were mis-filed, mis- categorized or even if they were even documented at all.

I wonder how we all will use this for our Supplier Qualification requirements

Well look how many of us use the ARC as our blood supplier and we all know what kind of hot water they have been in with FDA! My point here is that this issue with Immucor does not mean that we should run out and find another vendor even if we had a plentiful choice. They are too big for FDA to pull the plug as was stated before. There are plenty of facilities that operate under a consent agreement and still produce quality products.

I can't believe there was no mention of problems with the false positive Fetal Screens. That problem has not been corrected. The past 2 CAP surveys had samples with false positives (the latest survey results aren't back yet, but I predict an ungraded sample on that survey, as on the previous survey)

Immucor has issued a letter regarding this. Conatct your sales rep. Our rep assured us that they are working diligently to resolve any quality issues and that this will not happen.

Just received a recall today for a lot of Fetal Screens...false positive due to "particulate matter".

I didn't know that Immucor will have a problem with their quality. I thought since it's such a big international company, there should be quality assurance in place!

This thread really told me things that I wouldn't have know. I just printed out the letters for reading pleasure in my BB.

A rep from immucor told our supervisor not to worry.

A rep from immucor told our supervisor not to worry.

Of course they will ask you not to worry. -_-"

I can't believe there was no mention of problems with the false positive Fetal Screens. That problem has not been corrected. The past 2 CAP surveys had samples with false positives (the latest survey results aren't back yet, but I predict an ungraded sample on that survey, as on the previous survey)

We were amoung the 12% that got a false positive on the last CAP and have had 2 patients since. We switched to IMMUCOR when ORTHO was having problems with their positive control, found it easier to read so stuck with it. Anyone thinking of switching?