Serious 483 Issued - No Accountability Here

[FedsPleaseTakeActionNow]

https://wap.business-standard.com/a...plant-over-quality-issues-119042500434_1.html

“The 10-page Form 483 to Sun Pharma, which is issued to companies as an observation by investigators over deemed violation of US drug regulations upon completion of an inspection, also observed that the latter's Dadra plant's quality control unit lacked authority to fully investigate errors that have occurred. In other words, the quality control unit at the Dadra facility did not always ensure complete investigation of errors that may have occurred at the plant.“​

You’ll see the above 483 was issued late March, but the Dadra plant has faced actions in the past and nothing was done to address them (a Warning Letter is on the horizon).

We know there is not accountability from the top to the bottom.

If you work in the US and either handle commercial, manufacturing, or corporate issues, then we all know this company lacks actual oversight — Sun Pharmaceutical Industries Limited is running the show here. We know are US branded business is being run like its generic business. We know the company is part of so many criminal and civil lawsuits, from the opioid case to generic price fixing. We know sales and marketing have raised constant compliance concerns. Who’s in charge here? No one.

if you don’t believe any of the above, then you’re in denial and need an intervention.

WB

 

[anonymous]

https://wap.business-standard.com/a...plant-over-quality-issues-119042500434_1.html

“The 10-page Form 483 to Sun Pharma, which is issued to companies as an observation by investigators over deemed violation of US drug regulations upon completion of an inspection, also observed that the latter's Dadra plant's quality control unit lacked authority to fully investigate errors that have occurred. In other words, the quality control unit at the Dadra facility did not always ensure complete investigation of errors that may have occurred at the plant.“​

You’ll see the above 483 was issued late March, but the Dadra plant has faced actions in the past and nothing was done to address them (a Warning Letter is on the horizon).

We know there is not accountability from the top to the bottom.

If you work in the US and either handle commercial, manufacturing, or corporate issues, then we all know this company lacks actual oversight — Sun Pharmaceutical Industries Limited is running the show here. We know are US branded business is being run like its generic business. We know the company is part of so many criminal and civil lawsuits, from the opioid case to generic price fixing. We know sales and marketing have raised constant compliance concerns. Who’s in charge here? No one.

if you don’t believe any of the above, then you’re in denial and need an intervention.

WB

You know, the pieces are adding up. This is not an organization that is concerned with quality [read: patient safety] or ethical behavior.

Another FDA issue related to quality/manufacturing - how many times in the past few years ??? a CEO who paid a settlement for insider trading to avoid prosecution, numerous investigations and lawsuits and more.

Is this the company you want to depend on for your livelihood? Are you proud to say you work for Sun?

Not anymore.

 

[anonymous]

You know, the pieces are adding up. This is not an organization that is concerned with quality [read: patient safety] or ethical behavior.

Another FDA issue related to quality/manufacturing - how many times in the past few years ??? a CEO who paid a settlement for insider trading to avoid prosecution, numerous investigations and lawsuits and more.

Is this the company you want to depend on for your livelihood? Are you proud to say you work for Sun?

Not anymore.

Chill your jets. This is a company from India, a place that does not know from indoor plumbing. Even the clowns from India realize this. Ilumya, Absorica, all topical steroids--all made in the USA by contractors.

 

[anonymous]

Chill your jets. This is a company from India, a place that does not know from indoor plumbing. Even the clowns from India realize this. Ilumya, Absorica, all topical steroids--all made in the USA by contractors.

It’s not about the drugs we promote in our bag in the US, btw, I’m not sure each of the drugs you mentioned are in fact made in the US.
It’s a much bigger issue - an ethical one. You can’t say ‘I only steal in India and I only make unsafe drugs for countries for other parts of the world’ and keep your nose clean while in the US.