Sham Hall

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Here is what Abhay left out about the 483 that is available on the FDA website https://www.fda.gov/media/133737/download

OBSERVATION 1
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purported or are represented to possess.

OBSERVATION 2
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Specifically, your firm failed to establish and implement controls which ensure data integrity in the use of the environmental monitoring MODA EM PROD version 3.4 computerized system used by your Microbiology Laboratory for all microbiology samples including all sterile environmental monitoring.

OBSERVATION 3
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

OBSERVATION 4
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
**REPEAT OBSERVATION**

OBSERVATION 5
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

OBSERVATION 6
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

OBSERVATION 7
Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.

OBSERVATION 8
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
 






anonymous said:
Here is what Abhay left out about the 483 that is available on the FDA website https://www.fda.gov/media/133737/download

OBSERVATION 1
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purported or are represented to possess.

OBSERVATION 2
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Specifically, your firm failed to establish and implement controls which ensure data integrity in the use of the environmental monitoring MODA EM PROD version 3.4 computerized system used by your Microbiology Laboratory for all microbiology samples including all sterile environmental monitoring.

OBSERVATION 3
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

OBSERVATION 4
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
**REPEAT OBSERVATION**

OBSERVATION 5
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

OBSERVATION 6
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

OBSERVATION 7
Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.

OBSERVATION 8
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
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This is so Sun-like. Get away with as much as you can until you get caught, then, wiggle your ass out of it.

BUT, these observations appear to put patient health and safety at risk. That’s completely unacceptable and unbelievable.

This is like Abhay and the insider trading settlement that he and his wife made to avoid major prosecution. It shows a deep flaw in the character of the company.

This place is crooked. Period.

I’m outta here in 60 days, max.
 






anonymous said:
Here is what Abhay left out about the 483 that is available on the FDA website https://www.fda.gov/media/133737/download

OBSERVATION 1
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purported or are represented to possess.

OBSERVATION 2
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Specifically, your firm failed to establish and implement controls which ensure data integrity in the use of the environmental monitoring MODA EM PROD version 3.4 computerized system used by your Microbiology Laboratory for all microbiology samples including all sterile environmental monitoring.

OBSERVATION 3
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

OBSERVATION 4
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
**REPEAT OBSERVATION**

OBSERVATION 5
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

OBSERVATION 6
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

OBSERVATION 7
Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.

OBSERVATION 8
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
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it’s still shocking to see this omission. Is the criminal ? I don’t know.

c’mon, does anyone here respect ot trust Abhay ? Didn’t think so.
 






anonymous said:
it’s still shocking to see this omission. Is the criminal ? I don’t know.

c’mon, does anyone here respect ot trust Abhay ? Didn’t think so.
Click to expand...

Do you really need to ask the question, “Is this criminal?” I would say 100% this is criminal. To produce products which are not meeting the minimum standards for efficacy and safety?? It’s the equivalent to telling a lie. An omission of part of the truth is still a LIE. Ironic how SUN is all about “Compliance” in the USA but is so outside the “Compliance” lines in other countries.
 






anonymous said:
Do you really need to ask the question, “Is this criminal?” I would say 100% this is criminal. To produce products which are not meeting the minimum standards for efficacy and safety?? It’s the equivalent to telling a lie. An omission of part of the truth is still a LIE. Ironic how SUN is all about “Compliance” in the USA but is so outside the “Compliance” lines in other countries.
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What do these observations mean mean for that plant?
A warning with a follow up inspection?
 






anonymous said:
What do these observations mean mean for that plant?
A warning with a follow up inspection?
Click to expand...

Repeat observations are never a good sign. It will take some time before fda receives and reviews Sun’s response. The next step would be a Warning Letter and / or an import ban. Unfortunately for us consumers the fda gives companies a lot of chances to correct their behavior before coming down hard. Keep in mind that Sun is still under a consent decree for a handful of its facilities as part of the ranbaxy acquisition — sun is responsible for ensuring compliance and the major issue there was data integrity. Seeing data integrity issues here is not a good sign.
 






anonymous said:
Do you really need to ask the question, “Is this criminal?” I would say 100% this is criminal. To produce products which are not meeting the minimum standards for efficacy and safety?? It’s the equivalent to telling a lie. An omission of part of the truth is still a LIE. Ironic how SUN is all about “Compliance” in the USA but is so outside the “Compliance” lines in other countries.
Click to expand...
Not a supporter here but this is not a big deal. The violations are relatively benign. Most require protocol update and personnel training. Not much
 












anonymous said:
Repeat observations are never a good sign. It will take some time before fda receives and reviews Sun’s response. The next step would be a Warning Letter and / or an import ban. Unfortunately for us consumers the fda gives companies a lot of chances to correct their behavior before coming down hard. Keep in mind that Sun is still under a consent decree for a handful of its facilities as part of the ranbaxy acquisition — sun is responsible for ensuring compliance and the major issue there was data integrity. Seeing data integrity issues here is not a good sign.
Click to expand...

FDA won’t do a damn thing.
 












anonymous said:
okay abhay. makes sense and thank you for providing the insight.
Click to expand...

just an employee. No Abhay here! No loyalty to Sun beyond pay check!

FDA keeps issuing these observations, more so in India. They are not going to shut down the place. FDA is the last worry. The incompetence of the management and the internal corruption is the big threat not FDA!
 






anonymous said:
just an employee. No Abhay here! No loyalty to Sun beyond pay check!

FDA keeps issuing these observations, more so in India. They are not going to shut down the place. FDA is the last worry. The incompetence of the management and the internal corruption is the big threat not FDA!
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sun has had a very checkered past in the US. Caraco was shut down by the FDA - sun closed it down and moved the crap to another location (https://www.livemint.com/Companies/...-Detroit-manufacturing-plant-lay-off-178.html). Ohm had a facility subject to a consent decree (permanently closed) and has had many issues of its own at other facilities (https://www.fiercepharma.com/manufa...us-boxes-of-generic-claritin-made-at-ohm-labs). Sun has been consolidating its US facilities so it can focus on its facilities in India. So, FDA does care about India more because that’s where a majority of its products are coming from. FDA is a worry and impacts are relationships with physicians. I’ve already had a few tell me they won’t prescribe another sun product until it gets its quality issues under control.
 






anonymous said:
sun has had a very checkered past in the US. Caraco was shut down by the FDA - sun closed it down and moved the crap to another location (https://www.livemint.com/Companies/...-Detroit-manufacturing-plant-lay-off-178.html). Ohm had a facility subject to a consent decree (permanently closed) and has had many issues of its own at other facilities (https://www.fiercepharma.com/manufa...us-boxes-of-generic-claritin-made-at-ohm-labs). Sun has been consolidating its US facilities so it can focus on its facilities in India. So, FDA does care about India more because that’s where a majority of its products are coming from. FDA is a worry and impacts are relationships with physicians. I’ve already had a few tell me they won’t prescribe another sun product until it gets its quality issues under control.
Click to expand...


I’M JUST SO PROUD TO TELL ALL MY
FRIENDS AT HOLIDAY PARTIES THAT I WORK FOR SUN.
(it’s so embarrassing)
 






anonymous said:
sun has had a very checkered past in the US. Caraco was shut down by the FDA - sun closed it down and moved the crap to another location (https://www.livemint.com/Companies/...-Detroit-manufacturing-plant-lay-off-178.html). Ohm had a facility subject to a consent decree (permanently closed) and has had many issues of its own at other facilities (https://www.fiercepharma.com/manufa...us-boxes-of-generic-claritin-made-at-ohm-labs). Sun has been consolidating its US facilities so it can focus on its facilities in India. So, FDA does care about India more because that’s where a majority of its products are coming from. FDA is a worry and impacts are relationships with physicians. I’ve already had a few tell me they won’t prescribe another sun product until it gets its quality issues under control.
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I disagree. Physicians may be skeptical in general to generics because of news items - NMDA etc . Beyond the innovator brand, they don’t know much about other brands and genetics
 












anonymous said:
AG is in way over his head.
He was a big fish in India but he’s a minnow in the US.
The market has handed him his ass in a big way, and he’s cost the company hundreds of millions of dollars, not to mention the damage to the Sun brand equity (not that there really was any, but whatever it was, he’s taken it to about zero, if not a negative now).
He is arrogant, ignorant, a frickin’ bully -but I’m sure he’d back down if anyone ever stood up to him. So do it Princeton, you have no balls. Those guys are all in their late 50s, hanging on for any income, even if it means selling their souls. I have no respect for any of them now.
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Yup, I think that sums it up nicely.
 












anonymous said:
“India's leading pharmaceutical company Sun Pharma's manufacturing quality issues at its troubled Halol plant in Gujarat are continuing and may require at least three-four months to resolve.” https://m-businesstoday-in.cdn.ampp...-months-to-resolve-say-analysts/1/392646.html

Abhay lied right to our face when he said everything was fine.

#SunIsSettingOnSun
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And yet he still remains tanking whatever is left of the credibility this place had. Total bullshit.
 












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