ACell in the news!!!!

Looks like the jig is up!!!

Warning letter from the FDA to ACell:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm352061.htm

No shelf life? No complaint handling?

Why don't they send out this on a press release instead of a 1 year old publication... LOL

 

Does this report surprise anybody. If you look at everybody running this organization, there is zero experience in medical device industry.

 

name me one pharma or device company that doesn't have one of these bad boys. i think its evidence the company has grown out of 'start up' phase and is officially on the radar. not to mention warning letters are being issued at the highest rate in the last decade.

 

No need to worry, it is routine letter. Now that's some funny shit!!!!

 

Wow, interesting responses. Routine letter? I think you are getting the fact these letters are given out by the FDA routinely with thinking it is routine to get one. For example, cops gives out speeding tickets "routinely", it isn't "routine" to get one - most people get pretty pissed off.

Name one big company that doesn't have one... ok you got me there. I can name a lot of small companies that went public or were acquired that didn't get one. I think ACell is in that group for comparison. This isn't some sort of rite of passage. Ok maybe it is, this is like a fraternity freshmen getting his first lay and first STD from the fraternity skank because he didn't wear a condom.

If anything this is a wake up call for upper management, something needs to change - you aren't going to be advertising this as a good thing at the next investor meeting are yoy?

 

You notice people bringing up old post so this one isn't first. Nice try

 

It is still here. Hasn't gone away yet.

 

LOL its no big deal, but will try to manipulate the order of posts to hide it.

this is actually the way these idiots run the company too.. ignore/hide the bad news and hope no one notices

 

When it rains it pours. Looks like Acell is on the FDA Radar. Let's just hope that don't get wind of the off label promotion. POWDER EVERYTHING!!!

 

The funny/sad thing is that they never told us of the warning letter until it was posted on CafePharma. So those of you who say they arent monitoring this site are crazy. So instead of knowing about it and informing our customers (controlling the information) we were not told which allowed our competitors to use it against us. Ignoring bad situations is what 3rd graders do not medical device companies.
Please check time/date of the first thread and then the email response from our Director of Marketing, Werner Von Braun.
It's not very hard to believe that the guy puking in a garbage at last NSM gave "inadequate" responses to the FDA's letter. Did you read and understand it? Part of it was that ACell "piggybacked" data from wound sheets and applied it to the surgical products w/o any validation. Not a minor issue and if they do the validation and the surgical sheets have a less than two year shelf life, watch out.

 

LMFAO!!!... Great post regarding the timing of the email that went out to the salesforce. No SURPRISE!!!!

 

It is still here. Not going going away

 

hate to break it to you but that was also the week the fda posted the letter on its website. i doubt management monitors this site as much as you monitor acell. you should get over your vendetta and try selling some product. you may actually make some money.

 

Hilariuous! Does this even make sense? "I doubt management monitors this site as much as you monitor ACell". I just checked and FDA website and the warning letter was updated on 5/20, no idea if that was when it was first posted, but let assume it was last Monday. No word from ACell that this was on the web, I repeat nothing was sent to salesforce regarding a potential problem. Flash to last Friday and within 2 hours of it being posted here we receive an email regarding the letter.
I am a employee and should not have to "monitor" my company but it looks like we do. No way we wouldve even heard about this from corporate unless it was posted here. Maybe we should start "monitoring" the FDA website for news that our company should be sharing with us from the start.

 

what do you mean by "we"? we all know you're an ex-rep. the real "we" still work here, and are still trying to sell product, heal patients, and make a living. you really need to move on with your life. your anger is unbecoming.

 

Idiot. Why would I get the email on Friday if I was not an employee? Not angry just frustrated.

 

oh, i didn't realize it was inconceivable that you would have the email forwarded to you from someone still at the company. you're right, sorry about that.

 

The FDA warning is a good start, but this unethical company deserves a lot worse. I would really like to see a investigation into all of the off label promotion that the management expects of the salesforce.

 

I totally agree with the last comment. I like the fact that the FDA is on to them. Acell lied to me about what was off label and told me that it was fine to promote certain procedures that I NOW know are clearly off label. I was lied to again by Acell, wow big surprise. First about how much reps were making and now about off label uses. I just never thought a company would be so open about promoting off label use so I thought it had to be OK. My manager still gives me shit about not adding more powder to each case even though it is clearly off label. I am labeled a Goody Two Shoes because I won't knowingly break Federal Law. Can't wait to get out of here.

 

I don't know if the people in charge are really dumb and don't understand indications or just really shady and actually think that they will get away with this $#!+. Either way, it's not a valid excuse. The bad guys will not win this one, so I hope they enjoy the dirty money while it lasts, because another med device company will not touch you.