Alcami /AAI Pharma

Quote
anonymous said:
but they are hiring like crazy?
Click to expand...


That is because this place has a rotating door...people are leaving like crazy .....so they hire like crazy. What that means for the customer is new, poorly trained people, who make mistakes, are working on their projects. That results in low quality because the QC/QA staff is equally new and misses many errors. Many people stay only long enough to get a little cGMP experience so they can move to a better job at another company.
 






The holding company that owns Alcami is being acquired. Once ARES takes over ACAS this place will be sold to a new batch of clowns or even worse taken public again, in that case the current batch of clowns will be rich and we will be saddled with $400 MM of debt.
 






anonymous said:
That is because this place has a rotating door...people are leaving like crazy .....so they hire like crazy. What that means for the customer is new, poorly trained people, who make mistakes, are working on their projects. That results in low quality because the QC/QA staff is equally new and misses many errors. Many people stay only long enough to get a little cGMP experience so they can move to a better job at another company.
Click to expand...

cGMP experience is a pretty low commodity these days as most companies get dinged by the FDA after audits. Pharma itself is a pretty lousy industry with too many regulations and poor career choices.
 






Bottom feeding third rate companies do get 483's. The top tier companies don't. You don't hear about Catalent, PPD, Eurofins getting "dinged". AAI has gotten a number of 483s over the years, Alcami will get them too. Any company like Alcami that cut corners, has systems that are not robust, fails to have a culture of quality and generally is a horrible work place can anticipate client and regulatory audits that are not favorable.
 






anonymous said:
The holding company that owns Alcami is being acquired. Once ARES takes over ACAS this place will be sold to a new batch of clowns or even worse taken public again, in that case the current batch of clowns will be rich and we will be saddled with $400 MM of debt.
Click to expand...

How did you hear about this and when is it expected expected to occur?
 






anonymous said:
That is because this place has a rotating door...people are leaving like crazy .....so they hire like crazy. What that means for the customer is new, poorly trained people, who make mistakes, are working on their projects. That results in low quality because the QC/QA staff is equally new and misses many errors. Many people stay only long enough to get a little cGMP experience so they can move to a better job at another company.
Click to expand...

What's the percentage of turnover. There's always some turnover. Too much is a sign of problems

When did they have their last FDA audit?
 






A 483 is no problem. They are just a way to help companies get better. As long as the company realizes their mistakes and works to fix them things will be fine. Too bad AAI is not a company that takes these things seriously. Feds are gonna come with the marshalls and shut that dump down. Get out asap!
 






anonymous said:
Bottom feeding third rate companies do get 483's. The top tier companies don't. You don't hear about Catalent, PPD, Eurofins getting "dinged". AAI has gotten a number of 483s over the years, Alcami will get them too. Any company like Alcami that cut corners, has systems that are not robust, fails to have a culture of quality and generally is a horrible work place can anticipate client and regulatory audits that are not favorable.
Click to expand...

Actually Catalent has gotten a 483 last year for not testing stability samples within proper time frames. Alcami's upper management just does not care about their satellite sites. All efforts are placed at HQ and everything else gets swept under the rug.
 






anonymous said:
What's the percentage of turnover. There's always some turnover. Too much is a sign of problems

When did they have their last FDA audit?
Click to expand...

I'm not sure the percentage of turnover but in the 4 years that I was there, about 15 people have come and gone... and this is a site of ~35 people.

FDA visited HQ in 2014 I believe, there was nothing major. I know they have not visited the Durham site in over 3 years. A visit is right around the corner as a few clients have submitted NDA's recently and therefore the FDA will conduct audits at every site the client has done work at.
 






anonymous said:
I'm not sure the percentage of turnover but in the 4 years that I was there, about 15 people have come and gone... and this is a site of ~35 people.

FDA visited HQ in 2014 I believe, there was nothing major. I know they have not visited the Durham site in over 3 years. A visit is right around the corner as a few clients have submitted NDA's recently and therefore the FDA will conduct audits at every site the client has done work at.
Click to expand...
 






anonymous said:
I'm not sure the percentage of turnover but in the 4 years that I was there, about 15 people have come and gone... and this is a site of ~35 people.

FDA visited HQ in 2014 I believe, there was nothing major. I know they have not visited the Durham site in over 3 years. A visit is right around the corner as a few clients have submitted NDA's recently and therefore the FDA will conduct audits at every site the client has done work at.
Click to expand...


FDA audits are public record. Warning letters are published one the FDA web site as are some 483 observations.

http://www.fda.gov/ICECI/Inspections/ucm346077.htm

AAIPharma got a four observation 483 in 2013. The FDA is supposed to inspect every two years so there may have been another inspection in 2016 that has not yet been posted.

483 observations are a big deal for contract labs, it shows they have a problem. If those problems are not fixed then that can escalate to a warning letter, a serious problem for a contract lab or CMO. Just ask SK about what happened at Lonza. Clients will leave if you have repeated 483, they simply can't take the risk with their programs. They will run if you have a warning letter.
 






anonymous said:
FDA audits are public record. Warning letters are published one the FDA web site as are some 483 observations.

http://www.fda.gov/ICECI/Inspections/ucm346077.htm

AAIPharma got a four observation 483 in 2013. The FDA is supposed to inspect every two years so there may have been another inspection in 2016 that has not yet been posted.

483 observations are a big deal for contract labs, it shows they have a problem. If those problems are not fixed then that can escalate to a warning letter, a serious problem for a contract lab or CMO. Just ask SK about what happened at Lonza. Clients will leave if you have repeated 483, they simply can't take the risk with their programs. They will run if you have a warning letter.
Click to expand...

Clients will go to the cheapest place, warning letter or not. Don't let these people fool you. Warning letters happen to everybody from time to time. Pay some consultants and go on with business as usual.
 












There will be a waiting period once ARES takes ownership from ACAS. They will evaluate their various holdings and the management of each company. This turd will be one of the companies that get spun off. It has become an API manufacturing business, the labs will be the first asset to go.
 






anonymous said:
There will be a waiting period once ARES takes ownership from ACAS. They will evaluate their various holdings and the management of each company. This turd will be one of the companies that get spun off. It has become an API manufacturing business, the labs will be the first asset to go.
Click to expand...

Heard they're hiring quality talent solid dosage candidate. True?
 


















anonymous said:
Come on. Are really serious? Is the Wilmington site really this bad???

Their job postings are full of formulation scientists
Click to expand...

They are not top level talent. Formulating medicines that already have heavy generic competition is not a sign of a company that is innovative or pays well. Trust me, AAI is a place for kids fresh out of college to work just to get a year or two of pharma experience.
 












anonymous said:
if they only hire newbies, who in the heck teaches them and runs the show?
Click to expand...

Teaches? Hahahaha!!! Nobody teaches nobody. You go to AAI to learn what NOT to do in pharma. Thats why turnover is so high. People go there just to pad the resume and say they had a job doing pharma and then go somewhere else to learn how to do things the right way.
 






Top Bottom
Back
Quote