F.D.A. Chief Details 'Shocking' Conditions at Baby Formula Plant

[womanofthehills]

The Abbott Nutrition plant in Michigan that was shut down in February, sparking a widespread baby formula shortage crisis, had a leaking roof, water pooled on the floor and cracks in key production equipment that allowed bacteria to get in and persist, Dr. Robert Califf, the head of the Food and Drug Administration, told a House panel on Wednesday.

He detailed “egregiously unsanitary” conditions in the Sturgis, Mich., plant to lawmakers during a hearing, but he also acknowledged that his agency’s response was too slow in addressing problems at the plant.

“Frankly, the inspection results were shocking,” Dr. Califf told members of the House Energy and Commerce Subcommittee on Oversight and Investigations. “We had no confidence in integrity of the quality program at the facility,” noting the agency worked with Justice Department officials to dictate steps the company needed to take to turn the facility around.

For some reason link won’t paste. From yesterday’s NYT’s

[ProfessorGAC]

1. There's Probably 50 Violations Of The Law, There

And that DEFINITELY isn't cGMP.
I've been in proper cGMP facilities, and one could eat off any surface, anywhere in the site.
This is gross & willful negligence. And, I personally know a guy who was convicted of a felony for violation of environmental laws. It became a felony because it was considered willful.
No jail time, but long probation & a fine that required a second mortgage, plus the company got hit with punitive damages of $10 million.

[Roland99]

2. Link

https://www.nytimes.com/2022/05/25/health/fda-baby-formula-shortage.html

[Chainfire]

3. They make money selling product, not maintaining the facility.

You see the same things in commercial kitchens. It cost money to hire people to clean.

[kacekwl]

4. Abbott is hurting for money to fix this

Right. Maybe Abive subsidiary could led them a few bucks to clean things up. Or better yet give them a big fat government subsidy.

[dalton99a]

6. To patch the leaky roof and clean the floor

[dalton99a]

5. Lying, greedy sociopaths

Christopher Calamari, an Abbott Nutrition senior vice president, offered little explanation for conditions at the Michigan factory but said he was “deeply, deeply sorry” about the shortages. He said the company was coordinating 50 flights a week from its formula plant in Ireland to a dozen U.S. airports to increase supplies.

“We are committed to ensuring that this never happens again,” Mr. Calamari said.

Representative Gary Palmer, a Republican of Alabama, pressed Mr. Calamari for specifics about why the company did not fix problems at the plant before the F.D.A. forced its hand.

“We prioritize safety and compliance in our plants,” Mr. Calamari said. “And we’re committed to doing so and getting better coming out of this event.”