FDA Issued Notice "Clear and Present Danger"

M

mom2lillian

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fiercepharmamanufacturing.com/story/fda-cites-clear-and-present-danger/2009-12-08
">http://www.fiercepharmamanufac...ent-danger/2009-12-08
</a>
I am sure we all know there have been a number of recalls this year due to cepacia. This news bulletin stems from an initial analysis they have done on recalls and why. They will basically look at the information categorically to see what standards can be updated and systems put in place to remedy any trends which are seen. Despite the project not being close to done there must have been enough evidence for this to jump out at them. I am very glad it is getting more attention.

There is an entire facility where I work that I wont go in because they have in the past had a problem with B.Cepacia being found on some facility walls etc, the problem has been remedied but I go with the 'better safe than sorry' and dont even go in that facility. (and no to any inquiring minds this was not a product related finding it was routine monitoring to stop any problems from occuring)
 
M

mom2lillian

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fiercepharmamanufacturing.com/story/fda-cites-clear-and-present-danger/2009-12-08
">http://www.fiercepharmamanufac...ent-danger/2009-12-08
</a>
I am sure we all know there have been a number of recalls this year due to cepacia. This news bulletin stems from an initial analysis they have done on recalls and why. They will basically look at the information categorically to see what standards can be updated and systems put in place to remedy any trends which are seen. Despite the project not being close to done there must have been enough evidence for this to jump out at them. I am very glad it is getting more attention.

There is an entire facility where I work that I wont go in because they have in the past had a problem with B.Cepacia being found on some facility walls etc, the problem has been remedied but I go with the 'better safe than sorry' and dont even go in that facility. (and no to any inquiring minds this was not a product related finding it was routine monitoring to stop any problems from occuring)
 
M

mom2lillian

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fiercepharmamanufacturing.com/story/fda-cites-clear-and-present-danger/2009-12-08
">http://www.fiercepharmamanufac...ent-danger/2009-12-08
</a>
I am sure we all know there have been a number of recalls this year due to cepacia. This news bulletin stems from an initial analysis they have done on recalls and why. They will basically look at the information categorically to see what standards can be updated and systems put in place to remedy any trends which are seen. Despite the project not being close to done there must have been enough evidence for this to jump out at them. I am very glad it is getting more attention.

There is an entire facility where I work that I wont go in because they have in the past had a problem with B.Cepacia being found on some facility walls etc, the problem has been remedied but I go with the 'better safe than sorry' and dont even go in that facility. (and no to any inquiring minds this was not a product related finding it was routine monitoring to stop any problems from occuring)
 
M

mom2lillian

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fiercepharmamanufacturing.com/story/fda-cites-clear-and-present-danger/2009-12-08
">http://www.fiercepharmamanufac...ent-danger/2009-12-08
</a>
I am sure we all know there have been a number of recalls this year due to cepacia. This news bulletin stems from an initial analysis they have done on recalls and why. They will basically look at the information categorically to see what standards can be updated and systems put in place to remedy any trends which are seen. Despite the project not being close to done there must have been enough evidence for this to jump out at them. I am very glad it is getting more attention.

There is an entire facility where I work that I wont go in because they have in the past had a problem with B.Cepacia being found on some facility walls etc, the problem has been remedied but I go with the 'better safe than sorry' and dont even go in that facility. (and no to any inquiring minds this was not a product related finding it was routine monitoring to stop any problems from occuring)
 
M

mom2lillian

New member
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fiercepharmamanufacturing.com/story/fda-cites-clear-and-present-danger/2009-12-08
">http://www.fiercepharmamanufac...ent-danger/2009-12-08
</a><br />
<br />I am sure we all know there have been a number of recalls this year due to cepacia. This news bulletin stems from an initial analysis they have done on recalls and why. They will basically look at the information categorically to see what standards can be updated and systems put in place to remedy any trends which are seen. Despite the project not being close to done there must have been enough evidence for this to jump out at them. I am very glad it is getting more attention.
<br />
<br />There is an entire facility where I work that I wont go in because they have in the past had a problem with B.Cepacia being found on some facility walls etc, the problem has been remedied but I go with the 'better safe than sorry' and dont even go in that facility. (and no to any inquiring minds this was not a product related finding it was routine monitoring to stop any problems from occuring)
 
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