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"LILLY: PLANT ISSUES HOLD UP DRUG APPROVALS
The FDA's questions over some of Eli Lilly's manufacturing processes are holding up approval of the drugmaker's new products, including anti-psychosis and osteoporosis drugs. Marketing approval for the drugs depends on resolving those issues, the company acknowledged." (From Yahoo! News) Also see http://Hoovers.ym0.net/re3.asp?c=33982&p=100609&e=25654407 LifeForceDancer


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No. of Recommendations: 12
Of all the people in the world, with the addition of a few others, I can't conceive that Eli Lilly would be confronted with violations of GMP. I cannot but believe that these matters will end up being shown to have no real basis in fact.

RSH.
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They had some problems in the '80's. Something to do with old products made for their employees - vitamins and such. The FDA decided to make an example of them and threw the book at them over cleaning procedures. The massive 483 that resulted became textbook for the industry - I think they were offering courses on it for QA/QC people.

I think the pendulum swang too back far in Lilly's case - overreaction cost them alot of money stifling advancements, and excessive red tape. From a business standpoint, I'd prefer to see them go for the D- come audit time (OK - maybe a C+), but if you go for the A+, you spent way too much time and money, and it didn't get you, your customer, or your shareholder anything. I would suspect that in this instance, they got a minor 483 letter from the inspector saying that they need to rewrite their procedure on how to write procedures, and maybe change the significant figures on a raw material spec before proceding. Given Lilly's history, this is probably an A- (read: good thing), and won't be much of a speed bump.
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No. of Recommendations: 11
RE:
Challenges
Author: C172M Date: 12/31/01 1:14 PM Number: 755

I think the pendulum swang too back far in Lilly's case - overreaction cost them alot of money stifling advancements, and excessive red tape. From a business standpoint, I'd prefer to see them go for the D- come audit time (OK - maybe a C+), but if you go for the A+, you spent way too much time and money, and it didn't get you, your customer, or your shareholder anything. I would suspect that in this instance, they got a minor 483 letter from the inspector saying that they need to rewrite their procedure on how to write procedures, and maybe change the significant figures on a raw material spec before proceding. Given Lilly's history, this is probably an A- (read: good thing), and won't be much of a speed bump.
#---

Well, Lilly's having been in business since the they were making Merthiolate for any of the Flintstone family that had a cut or scrape ought to count for something. It's been fairly routine to give employees access to "outdated" stuff that everyone knows is still perfectly good for several years after the expiry date. I don't think LLY or anyone else would knowingly give or sell to anyone, anything that was not manufactured in reasonably safe conditions.

Some major maker of vaccines ought to take over that plant in Michigan, or else the government should push all that back onto Fort Detrick, as far as the Anthrax vaccine goes; the complaints about particulates and cloudy product would give anyone pause before administering or receiving a vaccine made by that facility.

Considering that stuff is now being warehoused to potentially vaccinate the entire US population, one would think the FDA would have those people up to their eyeballs in GMP, and have inspectors onsite on a permanent basis.

If this is all this was, I agree Eli Lilly doesn't have much to worry about.

RSH.
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