FDA Issues ANOTHER Warning Letter

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You can't comply from your corporate office which handles all your labeling, documentation, for plants outside the US. The corporate guide lines which plants use as a baseline to develop their own plant procedures are inadequate and your device strategy is flawed so says the FDA. Add to that anyone left at Hospira that understood the legacy pump business are few in numbers. The people you knew how to manage that business and had done so for over 20 years are long gone. Now what do you do ??

Better unload the device business quickly and focus your efforts on the solutions plants. If not, this house of cards is ready to come crashing down.
 






Mike Ball says there's nothing to worry about, all companies get these, and the FDA are happy with our plans, the warning letter was just based on the here and now not the remediation plan. Surely the 483 was the here and now statement, the warning letter was a rejection of the remediation plan.

Consent decree I believe
 






Anonymous said:
Mike Ball says there's nothing to worry about, all companies get these, and the FDA are happy with our plans, the warning letter was just based on the here and now not the remediation plan. Surely the 483 was the here and now statement, the warning letter was a rejection of the remediation plan.

Consent decree I believe
Click to expand...


Yea....Nothing to worry about.....

Yet they spend hundreds of millions trying to fix this. Hiring an army of consultants, upgrading equipment that is ancient, firing plant managers, etc. Still operations are in disarray, employee's are not properly trained, moral sucks, management is worried about getting their big bonuses and stock options. That is just the beginning of the problem.
 
























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