We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Shortly after receiving an FDA warning letter for alleged major quality deficiencies, an Indian vaccine maker was slammed for data integrity issues and GMP violations by the World Health Organization. Read More
Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections. Read More
There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Read More
A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
Two compounding operations are facing FDA allegations for producing adulterated drugs and doing so without prescriptions following agency inspections. Read More
The Office of Prescription Drug Promotion issued a warning letter to Shionogi, for omitting risks and material facts, for its head-lice lotion Ulesfia in a patient co-pay assistance voucher. Read More
British authorities say serious GMP deficiencies continue to plague Rusan Pharma’s Gujarat manufacturing facility, prompting them to reject all drugs from that site until it is compliant. Read More