Intarcia Therapeutics

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Auction week at Intarcia - 2 (two) days of fun filled used equipment

Don’t miss your chance to scoop up the equipment that led to failure

lab equipment for faking purity and sterility on Wednesday

IT equipment for endless pointless resubmissions of unacceptable information on Thursday

own a piece of failure
 



Auction off sales force laptops on Jan 28

go to rabin

10 Samsung 75” UHDTV only slightly used watch movies of Kurt strutting around and crowing like a cock

Complete Plant Closure of the Intarcia Biotech Hayward CA Site
 






























I remember when I was asked to help come up with a cleaning validation program for all the parts that needed to be qualified in the two washers in the manufacturing area. I came up with a plan to do the characterization of soiling, the plan for recoverables to do maximum allowable carryover, the training regimen for the techs who were to be qualified to do the recovery swabbing, sourced stainless steel coupons for the soiling and recovery tests... on and on. Now, I'll admit I'm not the strongest SME when it comes to developing cleaning programs, so that should tell you something when they handed it to me to develop their small parts cleaning plan. My background is in thermal validation, FFS. So I present this cleaning program to Ka Kam (asshead) and some other department heads and was told that it would be too expensive to implement. Besides, they had already qualified the parts washer.

And here's what they did to qualify it, I shit you not:
1. Take parts to be washed and wash them once.
2. Weigh parts to be washed; record weight.
3. Soil parts to be washed; record weight.
4. Wash parts again.
5. Weigh parts after washing.
6. Do parts weigh the same as when they were clean? Do they look clean?
7. If yes to both questions, then the cleaning cycle is now qualified to a level that is beyond reproach from the FDA.
8. ???
9. Profit!

I told them that their idea of "kwalificashun" wouldn't work and they needed to have an actual industry standard cleaning validation program. You plan on putting this device IN PEOPLE, right?? Those parts you plan to clean will be product contacting, right?? YOU NEED TO DO THIS. They told me that it wasn't a priority.

Somewhere on the CRLs from the FDA is a lack of a competent cleaning program. I'd bet my left ball on it.
Don't even get me started on the never ending deviation and CAPA generator that was their metrology and calibration department.

Anyone else remember when Ka Kam walked into the cleanroom leading a tour IN THEIR FUCKING STREET CLOTHES? So much fuckery...

So yeah, it definitely was Theranos II: 483 Harder.
 






And whatever happened with Safecor who was to do the device kitting? Did they ever have a Pre-Approval Inspection from the agency for ITCA? Not that they needed any more 483s. That was the most blatant nepotism I've ever seen. OH college buddies with NO experience awarded a major contract and there was NOTHING that could be done about it.
 



The US Department of Justice Criminal Resource Manual Section 941.18 USC 1343 cites these as the key element of wire fraud:

1 that the defendant voluntarily and intentionally devised or participated in a scheme to defraud another out of money

2 that the defendant did so with the intent to defraud

3 that it was reasonably foreseeable that interstate wire communications would be used

4 that interstate wire communications were in fact used

If you have information the SEC website “Report Suspected Securities Fraud or Wrongdoing” has a confidential tip section

Documents used for communication may be submitted as well
 



The Mighty Midget of Mouth Squeeks ! KG and OH were such arrogant a*holes. Funny how quiet the big men on campus have gotten. You’d think the “No Analog” Hypsters would be demanding recognition for completely fucking investors
 



anonymous said:
for anyone who cared the signs of failure were highlighted in the press..

Lack of transparency in healthcare startups risks another Theranos implosion

there’s Intarcia, the developer of a device for diabetes treatment that’s worth $5.5 billion. That company had its device rejected by the FDA and was forced to lay off staff and halt a couple of later-stage trials. It had only published six papers — none of them very highly cited.

Ultimately, the researchers concluded that highly valued healthcare startups don’t contribute to published research and that the valuation of these companies by investors is divorced from any externally validated data.

For the researchers (and for investors) this should present a problem.
Click to expand...
 



anonymous said:
And whatever happened with Safecor who was to do the device kitting? Did they ever have a Pre-Approval Inspection from the agency for ITCA? Not that they needed any more 483s. That was the most blatant nepotism I've ever seen. OH college buddies with NO experience awarded a major contract and there was NOTHING that could be done about it.
Click to expand...

Psst, litigators. Do some forensic accounting on the multitude of VP's lapdog consulting firms, and schlocky outfits like Safecor (OH reported to be the investor), KG's artsy-fartsy sis to name a few for money siphoning and kick-back schemes. Now how much was paid to Safecor for facility/CAPEX, cost of goods, and millions in development?
 






What’s the difference between wire fraud and mail fraud ? To be racketeering does the fraud have to be multiple times of the same fraud or a combination of different crimes ? For example if the leadership used a fake consulting group to bill Intarcia large sums so they could take the money is this kick back or embezzlement. What about bonus money paid based on fake claims to investors if they skim a percentage of the amount raised and pay themselves whole that be a form of money laundering. When the titanium inventory disappeared what does that count as ?
 



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