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(The Hill)   If you are aware how long it takes the FDA to "fully" inspect a factory, well... Let's just say don't count on many J&J Covid Vaccine doses any time in the near future   (thehill.com) divider line
    More: Followup, Vaccine, Emergent BioSolutions, J&J, new Johnson, vaccine material, Manufacturing, Vaccination, Federal regulators  
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1906 clicks; posted to Main » on 19 Apr 2021 at 8:25 PM (3 weeks ago)   |   Favorite    |   share:  Share on Twitter share via Email Share on Facebook



34 Comments     (+0 »)
View Voting Results: Smartest and Funniest
 
2021-04-19 6:58:49 PM  
I'm going to start deliberately accidentally my submissions.
 
2021-04-19 8:27:15 PM  
Hire a temp worker for $15/hr to do QC, what's the worst that could go wrong?!
 
2021-04-19 8:35:52 PM  
Probably just as well.
 
2021-04-19 8:36:03 PM  
I work in a facility that manufactures medical/surgical devices. FDA is worse than the IRS. And you can take that to the bank.

/robertblakeasbarettawithcockatooonsho​ulder.jpeg
 
2021-04-19 8:39:13 PM  
Almost like regulation harms businesses and in this case society as well
 
2021-04-19 8:40:12 PM  

Warlordtrooper: Almost like regulation harms businesses and in this case society as well


Don't cut yourself on that edge.
 
2021-04-19 8:40:21 PM  

Melvin Lovecraft: I work in a facility that manufactures medical/surgical devices. FDA is worse than the IRS. And you can take that to the bank.

/robertblakeasbarettawithcockatooonsho​ulder.jpeg


Also work in that industry. Can confirm.
 
2021-04-19 8:42:56 PM  

Warlordtrooper: Almost like regulation harms businesses and in this case society as well


Uh huh. Well, have some thalidomide to calm down, okay?
 
2021-04-19 8:44:54 PM  
As long as it takes the C -Levels to wine and dine the GS-15s at the FDA and for the GS-12s to do a powerpoint presentation to the mid level administrators, health and security folks.  Then, Friday afternoon, all the besties have a big meet and greet in the conference room and a five minute tour of the plant before leaving at 1:30.
 
2021-04-19 8:49:34 PM  
We're never getting through this pandemic.
 
2021-04-19 8:49:52 PM  
media2.giphy.comView Full Size
FULLY

 
2021-04-19 8:51:50 PM  
About time.
 
2021-04-19 8:54:42 PM  

Needlessly Complicated: Melvin Lovecraft: I work in a facility that manufactures medical/surgical devices. FDA is worse than the IRS. And you can take that to the bank.

/robertblakeasbarettawithcockatooonsho​ulder.jpeg

Also work in that industry. Can confirm.


um, should not the FDA, the organization ensuring that medical devices and drugs be safe, BE farking tough on manufacturers?

Just curious, who here WANTS them to NOT be a strong regulator of these industries?
 
2021-04-19 8:56:59 PM  
Wait till someone's finger gets loped off and they get the FDA OSHA tag team.
 
2021-04-19 9:01:25 PM  
"quarantine existing material"

I get a little twitch in my eye and a wave of nausea every time I read the word "quarantine". I have three little kids and a wino wife, you see.
 
2021-04-19 9:01:59 PM  
I just today got my invtatyfkr a vaccine. I signed up for them both. Give me all the blood clots as long I get my fix

I left that word there on purpose for how absolutely stupid iPhone text replacement can be.
 
2021-04-19 9:06:42 PM  

Wanderlusting: We're never getting through this pandemic.


Nope. This is our lives for the foreseeable future.
 
2021-04-19 9:08:21 PM  

Stibium: Hire a temp worker for $15/hr to do QC, what's the worst that could go wrong?!


But qualified people want a lot of money! What about my quarterly bonus?
 
2021-04-19 9:09:24 PM  

Needlessly Complicated: Warlordtrooper: Almost like regulation harms businesses and in this case society as well

Uh huh. Well, have some thalidomide to calm down, okay?


Don't
.
.
.
Flip out

Eeeyyyaahhhh
 
2021-04-19 9:12:59 PM  

TheReject: I just today got my invtatyfkr a vaccine. I signed up for them both. Give me all the blood clots as long I get my fix

I left that word there on purpose for how absolutely stupid iPhone text replacement can be.


I'm hoping to get my invocation soon.
 
2021-04-19 9:14:00 PM  

Bowen: Stibium: Hire a temp worker for $15/hr to do QC, what's the worst that could go wrong?!

But qualified people want a lot of money! What about my quarterly bonus?


Contract manufacturers are like Roman slave galleys.  There's always the drum beat saying "row faster, or no food this week".
 
2021-04-19 9:15:04 PM  
I did my time in an FDA regulated industry and frankly I'd have to be pretty damn hungry to go back to profiting off of the poor lifestyle choices so many people make.
 
2021-04-19 9:26:10 PM  

Warlordtrooper: Almost like regulation harms businesses and in this case society as well


Yeah, I long for the days of DDT and lead paint
 
2021-04-19 9:37:11 PM  
I recall the quiet McNeil recall of 2010. For you kids out there, McNeil makes Tylenol and a few other brands. See, they were getting complaints from customers about a musty smell coming out of their products. Upon inspection, they found that raw materials were being shipped on chemically treated pallets that leaked the chemicals into the raw materials. Nothing dangerous, just stunk. So, McNeil in their infinite wisdom instead of issuing a recall, quietly started sending in mystery shoppers everywhere to buy up their products. It didn't work. The FDA eventually found out about it. Now, if they had done a proper recall and told the FDA what they were doing, it would have been a 1-3 month delay. No big deal. It ended up being an 18 month recall because they tried to hide it, the FDA decided "you know, now is a great time to do surprise inspections to your plants" and found farking abhorrent conditions. Rat and bird droppings in production lines, materials stored incorrectly that could be fatal, just a whole hornets nest of shiat.

Point is: be ahead of the game and be honest with your problems and the FDA might not snoop around.
 
2021-04-19 9:48:25 PM  

Needlessly Complicated: Melvin Lovecraft: I work in a facility that manufactures medical/surgical devices. FDA is worse than the IRS. And you can take that to the bank.

/robertblakeasbarettawithcockatooonsho​ulder.jpeg

Also work in that industry. Can confirm.


The issue is the FDA does not have enough people or clout to actually do the job, so they send the inspectors to basically work for the company and let them hang if they actually try to do the job.

/BIL works as a food inspector.
//With no college I can get GS-13 tomorrow due to specialization, he likely will not see that sort of pay ever.
///He is probably the better man of the two of us.
 
2021-04-19 9:49:02 PM  

MarciusDecimus: Needlessly Complicated: Melvin Lovecraft: I work in a facility that manufactures medical/surgical devices. FDA is worse than the IRS. And you can take that to the bank.

/robertblakeasbarettawithcockatooonsho​ulder.jpeg

Also work in that industry. Can confirm.

um, should not the FDA, the organization ensuring that medical devices and drugs be safe, BE farking tough on manufacturers?

Just curious, who here WANTS them to NOT be a strong regulator of these industries?


Republicans. Next question.
 
2021-04-19 10:08:22 PM  

whisper in the wind: Wanderlusting: We're never getting through this pandemic.

Nope. This is our lives for the foreseeable future.


Lighten up, Francises. Aside from the least effective vaccine's production and distribution being temporarily halted, shiat's actually going really well. About a month from now we should be looking pretty good.
 
2021-04-19 10:25:04 PM  
Based on the number of people who developed clots vs the number of people vaccinated there is actually a higher chance that you will be injured in an auto accident on the way to your appointment than there is of developing clots.
 
2021-04-19 10:28:55 PM  
I was one of the leads (second shift) at a facility that bottled children's cough syrup (Zarbees) when we were visited by the FDA.

No warning letters. Just a few things were addressed. So insignificant that I cannot even recall.

We had a couple weeks warning though.
 
2021-04-20 3:27:29 AM  

Bowen: Needlessly Complicated: Warlordtrooper: Almost like regulation harms businesses and in this case society as well

Uh huh. Well, have some thalidomide to calm down, okay?

Don't
.
.
.
Flip out

Eeeyyyaahhhh


Too soon :/
 
2021-04-20 3:28:51 AM  

Drearyx: I was one of the leads (second shift) at a facility that bottled children's cough syrup (Zarbees) when we were visited by the FDA.

No warning letters. Just a few things were addressed. So insignificant that I cannot even recall.

We had a couple weeks warning though.


Which is BS.  Shouldn't be ANY warning.

Don't like it?  Don't sell things that go inside people.
 
2021-04-20 3:30:14 AM  

Noah_Tall: Based on the number of people who developed clots vs the number of people vaccinated there is actually a higher chance that you will be injured in an auto accident on the way to your appointment than there is of developing clots.


Different drug, different problem, I think...
 
2021-04-20 8:06:03 AM  
It's only like 65% effective anyway.  Leave that shiat shut down.  They made an inferior product and should have been told to either improve it or throw it away.  It's the consolation prize of vaccines.
 
2021-04-20 2:48:21 PM  

MarciusDecimus: Needlessly Complicated: Melvin Lovecraft: I work in a facility that manufactures medical/surgical devices. FDA is worse than the IRS. And you can take that to the bank.

/robertblakeasbarettawithcockatooonsho​ulder.jpeg

Also work in that industry. Can confirm.

um, should not the FDA, the organization ensuring that medical devices and drugs be safe, BE farking tough on manufacturers?

Just curious, who here WANTS them to NOT be a strong regulator of these industries?


Don't get it twisted, FDA inspections and oversight are important,

However, you have to understand being on the receiving side of an FDA inspection can turn an entire drug or device manufacturing site upside-down for days.

/Ugh, just give us the 483 now and get it over with.
 
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