Strictly speaking, it isn't. It's just negligence on an epic scale.
Abbott, based on what has been reported by the whistleblower to the FDA last October, has been hugely negligent in running the Sturgis plant. The FDA for its part has been hugely negligent in fulfilling its regulatory oversight function regarding Sturgis--having set up the regulatory structure to police infant formula manufacture, the FDA then chose to ignore their requirements within those regulations and didn't conduct proper inspections or respond to the whistleblower's allegations in a timely fashion.
The FDA was negligent again in its handling of the reports of Cronobacter contamination in infant formula produced at the Sturgis plant. According to the FDA's own testimony, while their tardy "for cause" inspection did find Cronobacter at Sturgis, it did not match the Cronobacter strains found in infant formula consumed by infants sickened as a result. So even though they could not identify Sturgis as the source of the contamination, they issued a recall and closed the plant--and then apparently did nothing until last month.
Both the FDA and Abbott basically sat on their hands while the nationwide out-of-stock rates for infant formula went higher and higher and higher. They quite literally WATCHED it happen, and aggressive action in response wasn't taken until late May, and even then was inadequate.
No, there's nothing accidental about this. Every single facet of the infant formula shortage is the result of a bad choice made either by Abbott or the FDA.
Thank goodness the Marines on Guadalcanal were not so ill-prepared, even though the Navy abandoned them the next morning after loosing most of the fighting ships during the night!
True, but we expect (at least I expect) that level of incompetence from government bureaucrats. If government officials were actually capable of pouring piss out of a boot with the directions written on the heel they'd been in private industry--probably in mid-level management.
If the FDA was capable of doing that we'd have far less pharmaceutical phuckery than we do now.
Given the serial lunacies that have come out of the FDA, I have to wonder if the FDA requires its staff to get their credentials from a discarded box of crackerjacks and then fail an 8th-grade literacy test.
"Nope, you can't work here sir, you have more than three active brain cells. You're overqualified."
This level of incompetence can’t be a accident, in my opinion.
Strictly speaking, it isn't. It's just negligence on an epic scale.
Abbott, based on what has been reported by the whistleblower to the FDA last October, has been hugely negligent in running the Sturgis plant. The FDA for its part has been hugely negligent in fulfilling its regulatory oversight function regarding Sturgis--having set up the regulatory structure to police infant formula manufacture, the FDA then chose to ignore their requirements within those regulations and didn't conduct proper inspections or respond to the whistleblower's allegations in a timely fashion.
The FDA was negligent again in its handling of the reports of Cronobacter contamination in infant formula produced at the Sturgis plant. According to the FDA's own testimony, while their tardy "for cause" inspection did find Cronobacter at Sturgis, it did not match the Cronobacter strains found in infant formula consumed by infants sickened as a result. So even though they could not identify Sturgis as the source of the contamination, they issued a recall and closed the plant--and then apparently did nothing until last month.
Both the FDA and Abbott basically sat on their hands while the nationwide out-of-stock rates for infant formula went higher and higher and higher. They quite literally WATCHED it happen, and aggressive action in response wasn't taken until late May, and even then was inadequate.
No, there's nothing accidental about this. Every single facet of the infant formula shortage is the result of a bad choice made either by Abbott or the FDA.
"back to hell with thee, vile demons, and trouble us no more!" - exorcist team doing their jobs at the FDA
You're gonna need more holy water. A lot more.
These two episodes have certainly lowered my former good opinion of Abbott.
RAIN!
Yes, fucking rain!
Thank goodness the Marines on Guadalcanal were not so ill-prepared, even though the Navy abandoned them the next morning after loosing most of the fighting ships during the night!
The key words to remember: "no contingency plan".
That's systemic failure. Abbott apparently can't run a decent lemonade stand.
BRAVO, neither can the government, even subsidized by trillions!
True, but we expect (at least I expect) that level of incompetence from government bureaucrats. If government officials were actually capable of pouring piss out of a boot with the directions written on the heel they'd been in private industry--probably in mid-level management.
"When all else fails, read the directions."
If the FDA was capable of doing that we'd have far less pharmaceutical phuckery than we do now.
Given the serial lunacies that have come out of the FDA, I have to wonder if the FDA requires its staff to get their credentials from a discarded box of crackerjacks and then fail an 8th-grade literacy test.
"Nope, you can't work here sir, you have more than three active brain cells. You're overqualified."