The problems with Abbott's infant formula plant in Sturgis just get mysteriouser and mysteriouser. The New York Times reports that Abbott has finally agreed with the FDA to reopen the Sturgis plant:
The agreement stems from a U.S. Department of Justice complaint and consent decree with the company and three of its executives. Those court records say the F.D.A. found a deadly bacteria, called cronobacter, in the plant in February and the company found more tranches of the bacteria later that month.
According to the complaint, the same Sturgis factory had also produced two batches of formula in the summer of 2019 and 2020 on different production equipment that tested positive for the bacteria.
Abbott staff “have been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants,” leading to the need for legal action, the documents state.
....The agreement said Abbott must hire a qualified expert to oversee a variety of improvements at the Sturgis facility.
The problems at the Sturgis plant appear to have been more severe than we've been led to believe:
Problems at the Abbott Sturgis plant surfaced in September during the F.D.A.’s first routine inspection there since the Covid-19 pandemic began. Inspectors discovered standing water inside the plant and personnel working directly with formula without proper hand hygiene, according to agency documents.
The following month, a whistleblower who worked at the plant filed a complaint under the Food Safety Modernization Act claiming that plant leaders celebrated concealing information from the F.D.A. and omitted key information from official documents.
The F.D.A. returned to the plant on Jan. 31 and discovered persistent problems, including the presence of cronobacter bacteria near production lines, according to agency records.
Obviously there's still information that none of us know. But tentatively, this sure sounds like an Abbott problem, not an FDA problem. Instead of stonewalling, Abbott could have fixed its problems in September—or, for that matter, in 2019 or 2020. But they didn't. Beyond that, they could have agreed to do what the FDA wanted back in February when they were first shut down. But it sounds like instead they argued and argued and argued, finally caving in only when the whole thing started getting lots of media attention.
It may be a while before we get the real story about Abbott's Sturgis factory, but for now all I see is the FDA trying to do its job and Abbott trying to take advantage of the FDA's limited resources in order to avoid having to do anything. Nor does it look like the FDA was being all nitpicky and unreasonable here. Abbott's plant in Columbus appears to be doing fine, after all.
Beyond this, maybe the FDA should deploy the threat of prison time for more than just three QA folks at Sturgis. Perhaps they should set their sights a little higher on the executive food chain?
IDK why you won't reference the oligopoly created via the stiff tariffs and import quotas. Are you secretly protectionist?
You raise a particularly good point. The bulk of the imported baby formula that both the Trump and Biden administrations have blocked was coming from Canada (not from China, the purchase of which is per se child endangerment). This is exactly the problem when domestic manufacturers are shielded from competitors. Biden should have fast tracked imports from Canada and the EU.
Actually, TFG did the initial clamp-down and discouraged imports from Canada. President Biden needs to roll that back.
Not clear to me how fast Canada or the EU can respond and ramp up though. As someone at Daily Kos mentioned a few months ago, JIT and lean production processes were adopted by Japan a long time ago BECAUSE THEY HAD NO CHOICE. The wide spread adoption of those philosophies and relentless cost cutting has come at the expense of resilience and speed of response. Too many industries aren't just lean, they are skeletal.
Great for the bottom line and for using small crisis to boost margin and gouge in general. Really sucks when one of the big players screws up.
Yeah they would have scaled back production when the US demand slowed back in 2019 and likely would take time for them to ramp back up
It isn't a question of Canada and the EU ramping up since they never scaled down during the pandemic. The interesting thing from a purely political point of view is that none of the company in this industry or in the forestry industry are major donors to either Biden or the Democrats yet he has placed their profits above his and his party's election hopes.
I'll bet they did a bunch of share buybacks, though. It's an oligopoly being run for high profit.
I worked as a human-factors engineer in air-traffic control research; I am now retired and speaking as a private citizen. In aviation safety, the US has separated the investigatory and regulatory functions, and as well maintaining its own expertise through research and the participation of non-industry, generally university-affiliated researchers and consultants. I wonder if this approach would work better in food and drug safety. One of the benefits of separation is that the findings and recommendations of the NTSB receive public attention through the media, and the public and especially, knowledgeable people from outside the process, have the opportunity to weigh and comment and critique findings and recommendations while the rule-making body, the FAA, is considering its response. The FDA's processes may be technically as transparent, but since they take place within a single organization, there is not the newsmaking characteristic of an independent agency producing formal reports on an issue of national concern.
Good ideas! The US government has been at the mercy of "Big Food" ever since food processing and manufacturing took hold, way back in the 1800s. It's a hard habit to break (hey, this is how we get FOOD!), but increasingly necessary in the modern era.
(Or does "modern" now mean the past, and we're "post-modern"? I no longer understand the language...)
Thanks! I could add, I think ‘regulatory capture’ is somewhat less likely when the functions are separated. The problem in the case of the 737MAX was that the function of engineering analysis was left to the company, so the certification process was not getting unbiased information from an independent organization.
"Perhaps they should set their sights a little higher on the executive food chain?"
In my experience it was always the higher ups responsible for ignoring regulatory guidelines and the QA folks' objections getting ignored and them being railroaded into signing off on bad shit.
Thats what I've observed, too. If I was a shareholder in the company, about now I'd be demanding the dismissal of the site manager, his immediate reports, and probably the COO too
Never try to argue with the FDA about inspection findings.
I worked for a short time with a guy who was an investigator with CDFA meat inspection. His name was Bill Shaline. Nice guy. Didn’t deserve this:
“On June 21, 2000, FSIS Compliance Officers Jean Hillery and Tom Quadros and California Senior Investigator Bill Shaline were shot shortly after they arrived at a USDA-inspected sausage establishment in San Leandro, California. California Food Inspector Earl Willis was also shot at, but escaped injury.
Operations at the establishment were suspended because the plant was not operating in compliance with food safety regulations. Rather than correct the problems, plant owner Stuart Alexander continued to illegally produce and sell products without the required Federal inspection. FSIS and the State of California began investigations to protect the public and detain product that was already found in commerce.
Hillery, Quadros, Shaline and Willis went to the establishment to meet with the owner to collect evidence and serve notice of the violations. The owner retrieved a gun from his office, entered the retail area where Hillery, Quadros and Shaline were waiting, and opened fire, killing the three investigators. Willis was waiting outside for police, who had been called to assist with meeting with the owner. Willis was able to escape by taking shelter in a local business.”
https://www.fsis.usda.gov/employees/employee-news-stories/remembering-their-sacrifice-jean-hillery-tom-quadros-and-bill
Alexander chased Willis while firing at them. Willis escaped and Alexander returned to his place where the not yet dead investigators were writhing on the floor. Alexander calmly walked up to them and shot them again. It was all captured on Alexander’s security camera.
This is an excellent example why we might want to reconsider the Constitutional prohibition of "Cruel and Unusual Punishments" for some particularly heinous crimes.
"Sausage Maker" Alexander deserved to be drawn and quartered on national television. Then his carcass should have been fed to his own hogs.
Id skip the drawn and quartered, let him get eaten alive by the hogs
Mr. Wu's solution.
"Cocksucka!"
"While awaiting execution on California's death row at San Quentin State Prison, Alexander, who had gained some 80 pounds during the four years in custody until his stay of execution, began to experience health problems. On Tuesday, December 27, 2005, Alexander was found dead in his prison cell. It was eventually determined that he had died of a pulmonary embolism"
From Wikipedia entry for Alexander.
The FDA has not been shy about pushing criminal charges if they feel misconduct is intentional rather than incompetence or lack of oversight. If I was in management at the Sturgis plant I would be talking to my attorney.
If I'm reading the AG's press release correctly (between the lines) he seems to be saying that he's giving them a pass for all past wrongdoing if they'll promise to ramp up production and possibly try a little bit harder not to kill any more infants than necessary. I think after the deal and the press release it would be pretty hard to go back and haul these guys in front of a grand jury. So I think all of these malefactors are in the clear.
One other problem this unveils...after all this, Abbott is not going to lose much business. Shuttering this plant will cost them, but that is short term. Long term, there's no one else to capitalize on their down time, i.e. pick up significant more market share.
This kind of thing is just a feature of the US definition of a corporation: an entity that makes money. Not "product" or "services", just money. Employees may think they're providing useful goods/services and have some pride in it, but management knows better.
I have no argument with Abbott being at fault.
But I am at a loss. Did no one at the FDA notice that the plant that was about to close represented such a large percentage of the formula supply?
Why did it take "panic in the streets" before anyone in government realized that the problem existed?
Crisis management instead of management.
The FDA should have made the problems at Abbott a priority. I have no problem with Abbott being at fault. But the FDA was asleep at the switch. Abbott executives should go to jail. But heads should roll at the FDA.
I think the FDA was too busy making nice with Pfizer to approve an injection that should have remained EUA only.