Baby Formula
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@George-K said in Baby Formula:
How about "newspaper readers?"
The whistleblower complaint about Abbott labs came forward in February. A month into the Biden presidency.
Abbott and the Food and Drug Administration were alerted to a whistleblower complaint about Abbott's Sturgis infant formula plant as far back as February 2021, ABC News has confirmed.
This complaint, filed with the U.S. Labor Department's Occupational Safety and Health Administration, alleges quality control concerns at Abbott's formula plant in Sturgis, Michigan -- a year before the company's massive recall and shutdown in February 2022 following contamination concerns, which helped exacerbate a nationwide shortage in baby formula, according to sources familiar with the matter.
OSHA received a complaint from a whistleblower on Feb 16, 2021, and sent a copy three days later to the FDA and Abbott, according to a person familiar with the matter.
The complaint raises further questions about when both Abbott and federal health authorities first knew about quality and contamination concerns at the Sturgis plant, and why it took so long for action to be taken.
The OSHA complaint, first reported by WSJ, alleges problems at the Sturgis plant like faulty equipment in need of repair or upgrade and inadequate safety validation for released product.
It was filed several months before similar allegations were made in another whistleblower report, which flagged contamination concerns at the Sturgis plant in October 2021, according to sources familiar with the matter.
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Now, the rest of the story …
If anyone still cares, Bloomberg published a nice article with timeline of events leading up to and the subsequent resolution of the baby formula shortage of 2022, with hindsight analysis and stories of individuals adversely affected by the tainted formula, etc.
Anyone here still seeing impacts of baby formula shortage on people you personally know?
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IOW, if the government had done what they were supposed to do, the chances are the company would have been in compliance.
But while local cops, firefighters, grocery clerks and hospital workers did their jobs (some who were fired for not taking the vaccine), the inspectors sat at home and collected their paychecks.
Always remember, Operation Valkyrie was an act of sedition.
Warning: I post things that interest me. Read and comment at your own discretion. -
@Jolly said in Baby Formula:
IOW, if the government had done what they were supposed to do, the chances are the company would have been in compliance.
… the inspectors sat at home and collected their paychecks.
What policy remedies would you suggest? More stringent inspection standard and more elaborate, higher frequency inspection schedules? Hire more and better quality inspectors? Retrain (and in some cases replace) the existing inspectors? (If you were to replace some inspectors, how would you identify who to replace, and how would you increase the likelihood that the replacements will work better than those replaced?)
Looking into the FDA’s funding history, the usual “the FDA has been chronically underfunded” complaints aside, I also see that the FDA is increasingly reliant on “user fees” (as opposed to Congress appropriated moneys) to fund its operations, meaning they are increasingly reliant on the businesses they inspect/regulate to pay their bills. Does this worry you that the regulator may get too reliant on and too chummy with the regulated? Would you rather see the FDA’s funding to go back to more Congress appropriated funds and rely less on “user fees”?
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Always remember, Operation Valkyrie was an act of sedition.
Warning: I post things that interest me. Read and comment at your own discretion. -
@Jolly said in Baby Formula:
Just showing up for the inspections you are supposed to be doing, would be a marvelous thing.
Do you know why or under what circumstances that has not happened? How would you go about making that happen? How would you go about making that happen systematically, reliably across large number of inspections across the nation?
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Health inspections should not be Mickey Mouse or punitive. The goal is to produce a quality product, be it food, healthcare or whatever.
Abbott has a corporate culture where they tend to cut a corner here or there. Years ago, Abbott owned the discrete immunoassay analyzer market with a box they named Axsym. They had some problems with reagent production according to the FDA and Abbott tried to argue the findings. This resulted in the FDA making Abbott pull most of their juice and left labs high and dry. No AHEP panels, HIV assays, etc. It wrecked their market dominance.
There is no question Abbott should have done a better job policing themselves, but the FDA didn't do their job at all.
There's another factor to consider...Why do we have so few companies making formula? Why didn't the Whitehouse act on a problem it knew it had, long before the supply problem became critical? And why didn't the FDA promote homemade formula recipes? The recipes are all over the internet, usually drawn from old infant care doctor's notes or medical books.
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If FDA inspections are anything like OSHA audits, they're stretched very, very thin and don't have anything like the resources they need to operate effectively as a policing authority.
Proud supporter of Plan 2525. Everything you think, do and say will be in the pill you took today.
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@Doctor-Phibes said in Baby Formula:
If FDA inspections are anything like OSHA audits, they're stretched very, very thin and don't have anything like the resources they need to operate effectively as a policing authority.
They're not as thin as OSHA, especially in certain areas. For instance, there is usually an inspector at any major meat processing plant almost every day, if not every day.
