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Re: hardlesson post# 63482

Friday, 09/15/2023 10:21:21 AM

Friday, September 15, 2023 10:21:21 AM

Post# of 65575
Currently Acting VP of Quality for SOHM building new facility and technology development.

International auditor, audited manufacturing operations and records at Sun Pharmaceuticals in India Faciliity in Halol as part of 483 remediation project.

https://www.linkedin.com/in/wm-dewey-rushing-7505a95/

"Sun Pharma is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US $5 billion. Supported by more than 38,000 employees globally and 43 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.

Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S. We are the 8th largest generics pharmaceutical company in the U.S. and are ranked 2nd by prescriptions in the U.S. dermatology market. We are rapidly ramping up our presence in the specialty branded market, with dermatology, ophthalmology and oncology as key target segments. Our U.S. business makes up 30% of our global revenue."

https://sunpharma.com/usa/

483 Remediation Project:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-12152022


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imo, Rushing knows what he's doing. hL shmn