FDA comes to agreement with baby formula factory to resume production

[BumRushDaShow]

Source: Washington Post




Abbott Nutrition, the maker of Similac and other popular baby formulas, on Monday said it has come to an agreement with the U.S. Food and Drug Administration to fix safety issues at a Sturgis, Mich., factory that has been shuttered for more than three months, contributing to a nationwide shortage of baby formula. "This is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage," said Robert Ford, chairman and chief executive of Abbott, who noted that the shortage was also exacerbated by a voluntary recall by the company of formula that had been possibly tainted by a bacteria that sickened and killed infants.

"We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years," he added. Once the FDA confirms the initial requirements have been met, Abbott could restart operations at the site within two weeks, the company said."The FDA is working closely with Abbott to bring the facility back online safely," White House spokeswoman Karine Jean-Pierre told reporters Monday afternoon. "That is the key here, safely. We want to make sure that it is done in a safe way.

We are very close to having a path forward to safely reopening the facility." She said the administration is also "moving as quickly as possible" to bring in more formula from overseas. In February, the FDA ordered Abbott to shut down its production facility in Sturgis, which produces Similac, EleCare and several other leading powdered formulas. Cronobacter bacteria had been found in infants who consumed formulas produced at the Sturgis plant. Two infants became sick, and two died. This prompted a voluntary recall by Abbott as well as an FDA inspection that found the plant did not maintain acceptable sanitary conditions.

On Friday, the White House announced that invoking the Defense Production Act to produce baby formula amid the shortage was on the table. Four major companies -- Abbott, Gerber, Mead Johnson and Perrigo Nutritionals -- control 90 percent of the infant formula supply in the United States. To make up for the Sturgis facility shortfall, Abbott has prioritized infant formula production at its other plant in Columbus, Ohio, converting other liquid manufacturing lines into making liquid Similac, and has brought in millions of cans of product from its Ireland production facility.

Read more: https://www.washingtonpost.com/business/2022/05/16/formula-shortage-fda-sturgis/

[TheRealNorth]

1. Why did it take so long to clean up a contamination issue?

Was their production process full of violations requiring an overhaul?

[oldsoftie]

2. Thats what I'm wondering; what the hell is the hold up?

You could steam clean the whole damn plant in a week. All the equipment maybe a couple more? I'm not In the business, I'm sure I'm missing something but its not 1922.

[NullTuples]

4. The key word is, "negotiated". Our federal agencies no longer have the power to demand anything.

But also it does make me curious as to whether there is more to the story. Such as, "the company had built up a backlog with so many new parents working from home and some choosing to breastfeed instead" and wanted to empty their warehouse. Or less conspiratorially, they got caught unprepared by a wave of enough new parents returning to working in the office and thus choosing formula. Or a million other possibilities.

No matter what else was happening I feel really bad for those parents. That's the sort of additional stress - and for many, cost - they didn't need after 2 years of pandemic.

[Lonestarblue]

8. The FDA seems to be one of the more bureaucratic agencies.

I can understand the need for safety and appreciate their vetting of drugs, though their approval of the Alzheimer’s drug that has little efficacy to back it up was ridiculous. Too often they have seemed to be on the side of big pharma. They move at a snail’s pace.

[LeftInTX]

13. It's crazy! I've had numerous issues with them

They took L-tryptophan off the market for over 20 years because of a bad batch!

I was taking it and pregnant when they took it off. I kept writing to them and writing to them. The only response: "We're not bringing it back"....

I think it finally reappeared on the shelves around 2008 or so...

[paleotn]

10. Their production process is huge and complex....

Most don't realize just how complex it is to make something like infant formula on an industrial scale. Like most incidents like this, it started with a whistle blower alerting FDA to Abbott's problems. FDA's speed or lack there of is neither here nor there. The fact that Abbott and / or its suppliers were cutting corners IS the issue and children died because of it. Fixing all that to the point where FDA thinks risk to the public is minimal takes time, lots of time and a whole bunch of Abbott's money. Just the shutdown itself cost Abbott Labs a fortune. Remediation to FDA's standards will cost many more fortunes. And rest assure, FDA will be living in Abbott - Sturgis's "shorts" for some time to come. That's the seventh circle of hell according to an old colleague of mine who works in pharma.

[Hoyt]

3. There was a problem at Abbot. But, it took FDA months to actually investigate reports.

FDA to investigate delay in baby formula plant inspection, commissioner says

WASHINGTON — Food and Drug Administration Commissioner Robert Califf said Monday that the agency will investigate why it took so long to dispatch inspectors to the Abbott Nutrition baby formula plant in Michigan.

In an interview on NBC’s “Today” show, anchor Savannah Guthrie said that the FDA received the first report in September about a sick baby whose infection was allegedly linked to baby formula produced at the plant in Sturgis, Michigan. A detailed whistleblower report about alleged safety lapses at the plant came out in October, but the FDA didn’t send inspectors to the facility until January.

Asked if the FDA was too slow to respond, Califf said, “We always want to be as fast as we can possibly be while also being diligent, remembering, as shown by this example, that if we didn’t close the plant, then we have a supply shortage, so we have to get this right.”

https://www.cnbc.com/2022/05/16/fda-to-investigate-delay-in-baby-formula-plant-inspection-commissioner-says.html


Whether faster FDA response could have stopped shutting the plant down is doubtful. But I don't doubt things went a bit slow after that UNTIL the formula crisis occurred and the finger pointing began.

[Warpy]

5. What hasn't ben reported enough is that Abbot got sloppy, babies got sick from it and 2 died.

That's why they had to shut down with the FDA breathing down the backs of their necks to do a complete cleaning of all equipment plus a really hard look at the lax policies and procedures that weren't followed that allowed contaminated formula onto the market.

Behind every tragedy is some greedhead who wants to look good to his bosses by shaving off a tenth of a cent on every run of product. That's most likely what happened here. Greedhead likely got his promotion then did a lateral job change before any consequences appeared.

[paleotn]

9. Bingo. Slow action and progress by FDA is irrelevant....

What is relevant is Abbott was running a dirty plant and children died.

[EarthFirst]

6. I wonder how far the 5.73 billion in stock buybacks would have gone in preventing any of this...

2.03 billion of which as recently as March 31, 2022

[paleotn]

11. Won't be doing that for a bit....

A big junk of cash is now earmarked for FDA's mandated remediation to the Sturgis site. Fines and legal costs to come are just the tip of the financial iceberg for Abbott.

[Marthe48]

7. I read they used their profits for stock buybacks

instead of making the repairs at the plant. This isn't what I saw, but reports that information:

https://efoodalert.com/2022/04/10/abbott-nutrition-what-price-profits/

[airplaneman]

12. A good video on this:

-Airplane

[orleans]

14. abbott came to an "agreement" with the fda?

wtf?
why didn't they just clean up their shit and correct the problem months ago?
this "agreement" sounds like the fda caved over some conditions and so now abbott is willing to do it

maybe i'm really misunderstanding things but that word is just throwing me off

fda should have just told them what they needed to do and they complied. agreement makes me think there was some weird compromise happening--which probably isn't a good thing when it comes to safety

[BumRushDaShow]

16. Here is the 483 issued to them after the last inspection

https://www.fda.gov/about-fda/fda-commissioner/abbott-laboratories-dba-abbott-nutrition-sturgis-mi-483-dated-03182022 (PDF)

(they spent about 6 weeks in there)

Earlier this year, 483s from 2019 and 2021 were released as well -

Documents show ongoing problems at infant formula plant linked to outbreak
By Coral Beach on March 22, 2022

The FDA has released documents showing a pattern of problems with food safety practices at the infant formula production plant implicated in an outbreak of illnesses that includes two deaths.

Form 483 documents from inspections in 2019, 2021 and 2022 of Abbott Nutrition’s Sturgis, MI, facility, show problems at the plant, according to the Food and Drug Administration.

(snip)

“The FDA is releasing the FDA Form 483s from three inspections conducted at Abbott Nutrition’s facility on Sept. 16-24 (PDF), 2019, Sept. 20-24, 2021 (PDF), and Jan. 31-March 18, 2022 (PDF). The inspectional observations in these Form 483s do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. FDA will take appropriate action in the future — if warranted — as we continue to evaluate the 2022 inspectional findings,” according to a statement issued with the documents.

(snip)

https://www.foodsafetynews.com/2022/03/documents-show-ongoing-problems-at-infant-formula-plant-linked-to-outbreak/

I even saw someone had FOI'd the EIR from 2019 (PDF).

And in response to this -

maybe i'm really misunderstanding things but that word is just throwing me off

fda should have just told them what they needed to do and they complied.

Well yeah, they do tell them "what they needed to do" and many times, these large companies have learned to hem and haw and it becomes a back and forth of document exchanges and then scheduling to go back in to inspect to make sure they are following their updated SOPs and make other corrective actions, etc (while the investigators are also inspecting OTHER firms in their regions). You have issues where in the media's zeal for a "gotcha", they downplay certain technical circumstances that inherently complicate the agency's evidence development.

For example, there had been complaints of infants who contracted a certain gram-negative Cronobacter bacterial infection, possibly from the product, but then it was found that geno-typed version found in the infants did not match the species found in the factory.

FDA, like most government agencies, has no criminal prosecution authority, and can only gather what evidence they have to hand off to DOJ (e.g., for injunctions, seizures, etc) if it gets to that point. But the agency does finally have mandatory recall authority for foods that meet the criteria, however the law requires allowing the firm time to voluntarily recall the product FIRST before going to that next stage, and that did happen here.

The bigger issue, like so much else that we have seen in the U.S., is the consolidation and monopolization of big corporations, so they essentially become "single points of failure".

[TiberiusB]

15. Stop me if this sounds familiar...Abbott knew what it was doing, putting profit over people...

https://mattstoller.substack.com/p/big-bottle-the-baby-formula-nightmare?s=r

[BumRushDaShow]

17. Abbott's problems go back decades

so this is nothing new.

Their drugs for example (in their Chicago plant) -

COMPANY NEWS; Abbott Labs Is Penalized

AP
March 22, 1990


The Food and Drug Administration has barred Government agencies from buying certain drugs from Abbott Laboratories, contending the company failed to correct violations of quality standards at a suburban Chicago plant.

The F.D.A. also said it would not approve any new drug applications by the North Chicago-based pharmaceutical giant that involve certain products made in the plant.

In a letter to Abbott dated March 14 but not released until Tuesday, the F.D.A. said some of the company's products were adulterated because of improper manufacturing practices. The agency's district director in Chicago, Raymond Mlecko, said F.D.A. investigators did not find unsterile products at the plant, but did see violations of Federal manufacturing requirements.

https://www.nytimes.com/1990/03/22/business/company-news-abbott-labs-is-penalized.html

They had also been under an injunction and consent decree when they had issues with their medical devices (diagnostic kits) in the past -

News > Companies
Abbott to pay U.S. $100M

November 2, 1999: 5:13 p.m. ET


NEW YORK (CNNfn) - Abbott Laboratories said Tuesday it will pay the U.S. government $100 million and temporarily stop making almost 300 medical-testing devices to resolve allegations it did not follow good manufacturing practices at its Lake County, Ill., facilities. Abbott, the nation's largest manufacturer of medical-diagnostic tests, will restate third-quarter financial results to reflect the charges.

The $100 million payment is the largest amount of money ever paid by a company regulated by the Food and Drug Administration for a civil violation of the Food, Drug and Cosmetic Act, the FDA said. Abbott (ABT) didn't admit to any violations of federal regulations at its Lake County, Ill., diagnostics plant in agreeing to the consent decree, which is subject to court approval. The company said its testing practices provide accurate results and no products will be recalled.

"The issues have to do with manufacturing processes and not with known instances of patient harm," said FDA medical devices chief Dr. David Feigal. The company said medically necessary diagnostic products for hepatitis, cancer, drug monitoring and fertility will continue. However, it will halt manufacturing and distributing other testing products until it proves that it conforms to federal quality standards.

(snip)

https://money.cnn.com/1999/11/02/companies/abbott/

And the above resulted in them breaking themselves up into separate units a decade ago. They also paid a huge fine in 2012 as part of a criminal prosecution by DOJ on behalf of FDA, for promotion of off-label use of one of their products.

Say the word "Abbott" and anyone who has been in the agency for a long time runs screaming out of the room...