Sun Pharma response to import ban lack sufficient corrective actions: USFDA

Report stated that FDA banned imports from Sun Pharma's Karkhadi plant in Gujarat in March

sun-pharma-fda

Sun Pharma failed to impose measures after the ban by USFDA

U.S. Food and Drug Administration said in a warning letter that Sun Pharmaceutical Industries Ltd's response to an import ban on one of its plants lacked "sufficient corrective actions.

Report stated that USFDA banned imports from Sun Pharma's Karkhadi plant in Gujarat in March.

Sun Pharma failed to ensure laboratory records had complete data and that manufacturing staff had inadequate training and experience, FDA was quoted as saying.

The Karkhadi plant, which makes the antibiotic cephalosporin, is one of Sun Pharma's 25 manufacturing plants.

Leave a Reply Sign in

Notify me of follow-up comments via e-mail address

Post Comment

Survey Box

Union Budget

Has Union budget 2017 addressed all requirements of healthcare industry?

Send this article by email

X