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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
French authorities are calling for the withdrawal of Anuh Pharma’s GMP certificate after an inspection turned up 24 alleged GMP deficiencies. Read More
An FDA audit of Indian drugmaker Lupin revealed four potential violations in two 483s at two of its production facilities, the company admitted in a note to the Bombay Stock Exchange Tuesday. Read More