Posted on 05/10/2022 1:44:13 PM PDT by algore
The biggest baby formula supplier in the U.S., whose Michigan plant was shutdown nearly three months ago, claims the bacterial infection that killed at least two infants did not come from their products.
In mid-February Abbott Laboratories issued a nationwide baby formula recall and ceased operations at its plant in Sturgis, Michigan amid reports of babies contracting bacterial infections from its products.
An Abbott spokesperson told DailyMail.com Tuesday that 'thorough investigation' by the U.S. Food and Drug Administration (FDA) and Abbott revealed 'infant formula produced at our Sturgis facility is not the likely source of infection in the reported cases and that there was not an outbreak caused by products from the facility'.
However, despite the findings of the investigation, the plant remains shuttered nearly three months later.
The FDA - which said it found food safety violations at the plant, as well as five strains of Cronobacter, a bacteria that can cause blood infections and meningitis - has refused to say when the plant can resume operations.
Abbott claims they are 'working closely with the FDA to restart operations' at the plant, with the spokesperson noting: 'We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall'.
The FDA told DailyMail.com it was holding discussions with 'Abbott and other manufacturers to increase production of different specialty and metabolic products'
Abbott alleges that none of the formula distributed to consumers tested positive for Cronobacter or Salmonella.
The manufacturer claims the FDA and Abbott officials both tested retained products for the bacterias and yielded negative results.
Abbott notes no trace of Salmonella was found at the Sturgis plant and the Cronobacter that was found in environmental testing during the investigation was in non-product contact areas
(Excerpt) Read more at dailymail.co.uk ...
The unvaxxed ones, anyway.
Just had a thought....
Is the shortage being generated by Deep State covering up something else? Distracting from something else?
Were those babies killed by something other than bad baby formula...?
But the jabs are fine for pregnant women
If there had been an actual contaminated product issue there would have been far more sick babies.
People would have noticed.
Sorry but the “nobody can follow the rules” is pure D horse crap. They’re in violation. It’s just that simple. Sure apparently they got lucky and none of it wound up in the product (which did get tested), but they failed inspection. Failed inspections happen, and now they have to deal with that. And that COMPLETELY answers the question of why they’re still shutdown.
Still, taking 3 months to fix issues is excessive and makes one wonder what exactly did the FDA demand be changed or fixed?
Were they ordered to purchase new equipment, replace plumbing? Seems like whatever it was, it be stuck in the supply chain somewhere.
You do have to wonder what they found. And where.
The regulations are so complex and so contradictory that they will find something wrong. You can get dinged because you did what the last inspector told you to do and this one decided to read the regulation another way. There has NEVER been a case, in the history of the FDA coming to do an inspection, where they have not found something wrong with the facility. That, BTW does not mean you fail the inspection. It means you have to do whatever the current bureaucrat decided you should do this time.
In this case your claim that they "failed the inspection" is wrong because, they didn't.
The FDA does not even try to claim they did.
They are claiming they "found violations" which is not the same thing and that they want them to "change their formula" which is not the job of the FDA.
And no, that is not the reason they are not back in operation and they did not "luck out" they were innocent of the charges.
So... once again, nice try to defend the soul crushing bureaucracy that starves babies, but you again failed. Miserably.
Do you not even read what your own bureaucrats said?
The FDA told DailyMail.com it was holding discussions with 'Abbott and other manufacturers to increase production of different specialty and metabolic products'
Read it again.
Slowly.
Do you see anything in that statement about there being something wrong with the facility?
If there was they would have said so, but they just babble about how they want Abbot AND OTHER MANUFACURERS, to make something different.
The FDA told DailyMail.com it was holding discussions with 'Abbott and other manufacturers to increase production of different specialty and metabolic products'
The FDA has decided to tell all baby formula manufactures that they need to make something different.
This was just an excuse.
Sorry but that’s excuse mongering horse crap. If you can’t manage to follow the rules you shouldn’t be in the business.
Found violations is the same thing as failed inspection. That’s how you fail, they find violations.
Yes it is RIGHT IN THEIR STATEMENT:
which said it found food safety violations at the plant, as well as five strains of Cronobacter, a bacteria that can cause blood infections and meningitis
There IS something wrong with the facility. Sorry you can’t be bothered to read.
This is from the FDA website.
Following the voluntary recall and hold of certain powdered infant formula products produced at the Abbott Nutrition facility in Sturgis, MI, Abbott has committed to completing enhanced testing of stored product batches prior to making release determinations. While the FDA recognizes that Abbott has conducted standard product testing, there were a limited number of samples tested. Additionally, although finished product testing does not eliminate the risk of contamination, the enhanced testing will provide for a greater chance to detect Cronobacter sakazakii, if present; however, this enhanced level of testing will take additional time.
In the meantime, the FDA has informed Abbott Nutrition that the agency has no objection to the company immediately releasing product to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas listed below on a case-by-case basis. The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products. In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection. https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-infections-powdered-infant-formula-february-2022?utm_medium=email&utm_source=govdelivery
So the hang up is the extended testing and dollars to donuts, the FDA lab or their designated lab is an FDA crony lab and probably does crap work so their results are inconsistent with the results from Abbot who probably hired a top tier independent 3rd party lab because they know better than to rely on FDA crony corporations.
I am also going to speculate that since Abbot states that there is no evidence that the babies died from contaminated formula that the DNA of the strain found in the infants didn’t match that found in the facility. The FDA is still looking for the smoking gun, hence the demand for extended testing, because without the exact match they can’t fine them until their eyeballs bleed.
From what I’ve read on food industry journals the initial findings were insufficient surface cleaning and handwashing.
This is government dipstickery at it’s finest. Time is on Abbot’s side since public pressure is mounting on the FDA to get out of the way.
You will always find bacteria, always. What matters is the concentration and where it was found. They found five strains, but did any of them match the strains found in the 4 sickened infants?
I’m betting not or they wouldn’t have ordered “extended” testing. They are still looking for evidence to base their fines on and 3 months later, they’ve got nothing.
Meanwhile, they’ve caused a nationwide shortage.
The bright side is, that a lot of new moms are going to be more committed to breast feeding as long as possible to avoid being caught in this nightmare.
You will always find bacteria. But what kinds and how much matters. And depending on what’s found whether or not it matches what made the kids sick is immaterial. If they came in looking for X but instead found very dangerous Y then that’s still a problem, not the problem the were looking for, but a problem. Abbott says the FDA found violations and they are working with the FDA to solve the problems. That to me is the WHOLE story, and everything else is just silly finger pointing.
The big THEY think we’re stupid.
Bless their hearts.
Country folk will survive.
It shouldn’t take 3 months to rectify the problems of surface cleaning and handwashing! Those are the problems they stated they found. That is normally rectified with a deep cleaning and retraining the entire staff on basic procedures again and again until you identify the lazy ones and replace them, etc. 3-7 days, possible a couple of weeks if machinery has to be substantially or completely disassembled.
3 months is somebody putting up roadblocks for a shakedown and the “extended testing” is probably the method. You might want to believe regulators are angels, but I am here to tell you that most of them are petty tyrants and a good percentage are grifters.
Something is not right in this scenario and I question why this extended testing is taking 90 days now. The obvious answer is that the FDA has still not found a matching strain of bacteria to base their fines on and continue to demand more samples for testing. Abbot has decided to wait it out until the public demand forces them to back off.
That’s why they are “allowing” emergency releases of product on a case by case basis. Another couple of weeks and they will release it all. They are in face-saving mode.
Also, they didn’t find “Y”. They found five strains of X that don’t match the strain found in the sick children. Believe me, if they had immediately found a match, they would have immediately ordered a fine of several millions and lawsuits from the families would be filed.
That didn’t happen, so you can bet what is going on is a delicate negotiation between the corporate lawyers and government grifters.
Then maybe that’s not the problem. I haven’t seen anything saying the scope.
As for allowing emergency releases, that’s just being useful and understanding this is a really important part of the supply chain. Also the story says the bacteria wasn’t in the food processing area. So that would be risky to employees but end product.
The only anybody here in face saving mode Abbott, trying to soft pedal that problems were found and they’ve done a crap job of fixing them.
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