Abbott, FDA were warned about formula plant a year before recall

dawp

Lifer
Jul 2, 2005
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did a search for Abbott and all I got was about the idiot down in TX.
ANYWAYS this seems like a significant revelation, they knew about possible trouble at the plant and did nothing until it could no longer be hidden.
 
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Leeea

Diamond Member
Apr 3, 2020
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A few decade ago I worked with QA in the food industry.

A bit familiar with the NSF*, SQF2000**, WI-DHS, ABA, and USDA*** standards. And passing the relevant audits.



What is so weird about this first complaint is that it was sent to OSHA. This is bizarre, and something a person on the line who did not understand the bureaucracy of food safety would do. Because of the source, it would 100% of the time be ignored. The guy who reported this was also likely fired shortly there after, anonymous or not this was likely either the machine operator or maintenance tech.


The "proper" way to deal with this is to quietly slip a note to a USDA inspector, which we all had personal non-work contacts for. Nobody ever did this. This sort of thing is career ending.

The actual way we dealt with problems was a verbal hint to the Heinz auditor, and use Heinz as a baseball bat to beat management into doing the right thing. The only way to influence a multinational is with another multinational. Heinz promotes its QA up from line workers and develops its QA all internally. They had a reputation for being sharp, but more importantly willing to deal with problems without making unnecessary waves.


*in my opinion the National Sanitary Foundation was the best with its random no warning audits and focus on practical food safety
**Safe Quality Food 2000 was Walmart's favorite audit and the auditor date/time is scheduled before hand. By far the most paperwork. Big focus on avoiding supply interruptions.
***The United States Department of Agriculture were very good and very hands on. I liked the inspectors. Always understaffed.




Speculation:

This problem was likely around a long time. Both management and QA were aware some of the containers were not sealing. They both likely were unconcerned because when the workers package the containers they have to squeeze them to lift them into the boxes. This likely would immediately betray any leakers.

Odds are there was a SOP on the wall next to the boxing to discard all containers that did not hold internal pressure.


This all worked fine for years. But then as the machines aged, the throughput rate on the line fell as discards increased. Management came down on the supervisor for substandard performance. Probably more then once, in the form of a write up.

The supervisor(s) likely then realized they needed to get creative. So they quietly changed the rules, to allow containers that were mostly good through.

This was fine for a while, but as the machines wore out the "mostly good" standard was relaxed.

And then we end up where we are today.
 
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eelw

Lifer
Dec 4, 1999
10,384
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Regulatory issues notwithstanding a "free market" would let us import comparable formulas from Canada and Europe instead of keeping them out for ill advised protectionist reasons lobbied for by US manufactures.
I never looked for stories, but I haven’t seen any of people driving up to Canada for formula. Wonder why not?
 

K1052

Elite Member
Aug 21, 2003
53,614
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I never looked for stories, but I haven’t seen any of people driving up to Canada for formula. Wonder why not?

This is possible from what I have read. Same with Mexico. Sort of limited utility unless you are close to the border though since it is for personal use only (can't buy a semi full for resale). IIRC the Trump admin worked hard to keep out imports in the USMCA to protect US dairy and formula manufacturers.
 

Leeea

Diamond Member
Apr 3, 2020
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I never looked for stories, but I haven’t seen any of people driving up to Canada for formula. Wonder why not?
Infant formula likely does not age as well as prescription drugs.
 

Lezunto

Golden Member
Oct 24, 2020
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Abbott Nutrition knew that equipment in its baby formula plant in Sturgis, Mich., had been contaminated back in February 2021.

This was months before some people knew how unsafe any product would be if manufactured at the Sturgis plant. Besides the equipment, which was contaminated with Cronobacter Sakazakii bacteria, the plant also had a leaky roof and its managers apparently ignored proper food safety protocols.

What is worse is that Abbott Laboratories, the parent of Abbott Nutrition, kept these concerns quiet until the FDA ordered a huge recall of newborn and infant formula after two children died. Four other babies were sickened.

The FDA ordered the Sturgis plant closed down in February 2022 until its equipment was bacteria free. The recall and the plant shutdown led to a nationwide shortage of baby formula. Price gouging hurt the poorest of new mothers.

Senate Finance Committee Ron Wyden (D-Ore.) tied Abbott Lab's recent stock buyback and paying of dividends to stockholders to the GOP's 2017 billion dollar tax cuts.

The Sturgis plant has reopened, but only for production of specialty baby formula.
 
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uclaLabrat

Diamond Member
Aug 2, 2007
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Yeah...FDA doesnt just walk in and shut you down. You have to demonstrate essentially willful ignorance/intransigence, especially for something this essential, for them to decide youre not pulling your weight and actually shut down ops.
 
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