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Abbott Laboratories Consent Decree based on continued GMP / QS violations

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Wes Bucey

Prophet of Profit
#2
Abbott HQ is less than 10 miles from my house. A large number of their quality people belong to one or both of my ASQ Sections. Even more "degrees of closeness" include the fact that several other members of my Sections made very large fees as consultants to Abbott after the FDA decree to "rehabilitate" the Abbott manufacturing practices.

Over the years, I have talked with many of the folks involved in that debacle and, to a man, they claim the root cause of their problems with the FDA were NOT faulty products reaching customers, but merely shoddy documentation prompted by upper levels of management who were used to "shortcuts" they could blame on low level employees and merely say to FDA, "Gee, that was a fault of Mr. X. We are resolving that by replacing him."

Well, FDA changed their policies and held top management liable for ANY shortfall in Quality practices, especially documentation. Understand that Abbott wasn't shipping products contaminated by foreign substances as the Johnson & Johnson OTC manufacturing plant in Pennsylvania was doing - they [Abbott] were arrogant and got caught by some FDA guys who were tired of having smoke blown up their hindquarters by Abbott managers. Most of the Abbott problems with FDA are resolved, but it cost Abbott millions of dollars in attorney and consultant fees before they were able to mollify FDA officers who didn't give up easily.

It is an object lesson I have alluded to in the past, both here in the Cove and over in the ASQ Discussion forums - "the FDA is in the process of a big-time reform and "technical violations" of Good Manufacturing Practices are no longer treated lightly."

This does NOT mean every FDA inspector is hard-nosed and looking for violations, but it does mean that when they find and report them, the higher officers in FDA will back them up and not roll over for an organization's top management which tries to lay the blame on a low level employee (the scape goat!)

The fact the Pennsylvania plant and its corporate parent are so "eager" to voluntarily recall their possibly-contaminated products is really a direct consequence of the hell the FDA put Abbott through. FDA is willing to go easy on an organization that 'fesses up and makes a good faith effort to remedy a situation BEFORE the FDA issues cease and desist orders.

In the long run, most risk analysis scenarios predict it is cheaper to do a voluntary recall than to get forced into one by the FDA, mostly because of all the soft costs of dealing with FDA in addition to the hard cost of recalling and destroying suspect products.

Let me make one thing clear:
the FDA agents are not always right. Any organization which truly feels the FDA has made an error in judgment should push back. The fact that so many organizations don't push back is probably not due to fear, but simply because the organization managers recognize they really are/were in violation of FDA requirements.
 
M

MIREGMGR

#3
Sometimes top management uses the lower tiers as scapegoats, but that's not always the full story.

Sometimes it's the case when one of these corporate regulatory disasters occurs that the RA/QA elements of the organization actually weren't doing a good job; were themselves taking "shortcuts" and allowing a culture of regulatory permissiveness and corner-cutting at multiple levels to enable operation with smaller budgets and fewer disruptions of the engineering process and production revenue stream; and were intentionally not communicating to higher corporate levels the resulting regulatory shaky ground they were on in return for those smooth operations. One of the medical imaging operations of GE Healthcare was essentially stopped from selling equipment for ~ 2 years because (as I understand it) their design validation practices turned out to mostly be obfuscation. My understanding is that a number of RA/QA people were replaced as a result of management's investigation into how this occurred.
 
S

Sorin

#4
One of the medical imaging operations of GE Healthcare was essentially stopped from selling equipment for ~ 2 years because (as I understand it) their design validation practices turned out to mostly be obfuscation. My understanding is that a number of RA/QA people were replaced as a result of management's investigation into how this occurred.
Just want to be sure I got it right...are you saying the management was NOT aware of the practices in question? I mean...really?
 

Wes Bucey

Prophet of Profit
#6
The plain and simple fact is top management was not exercising its oversight duties. Regardless of the company, lower and mid-level personnel do not operate in a vacuum; somebody higher up on the ladder had a duty to prevent chicanery and obfuscation, but chose not to do so. The fact any practices which violate regulatory requirements were ONLY detected/discovered by FDA agents and not in-house personnel with a duty to prevent such misfeasance/malfeasance is hard to swallow for any but the most naive observer.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#7
The real pity is that MANY of those assays were available on competitor platforms. The FDA allowed continuous manufacturing to avoid the cost to the healthcare system of switching platforms.
 
S

seanlaw

#8
Here is Abbott Diagnostics consent decree which barred them for years from making a lot of their own kits. It hurt them quite a lot in the market.

The decree was based on continued GMP / QS violations.
This is a good learning example.

Dear Colleague Letter: Abbott Laboratories Consent Decree
Sad, the link has been removed ... :(

Do you know what Abbott is saying now, " Abbott standards are FDA standards".

hmm... not sure, but I feel something is happening between FDA & A ... :notme:
 
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