Dr. Reddy’s blasted in warning letter for hiding existence of testing lab from FDA

Eric Palmer An FDA warning letter found that for years, Dr. Reddy's Laboratories was testing drug batches in a laboratory that the FDA was never told existed and often shipped to ...

Some psych experts want FDA to yank black-box warning on antidepressants

Emily Wasserman In the 10 years since the FDA found that antidepressants carried an increased risk of suicidal thoughts and behaviors in teens and slapped a black box warning on the ...

FDA flags particle problems in latest Hospira warning letter

Tracy Staton Hospira's FDA woes have moved to Australia. The agency scolded the U.S.-based company in a warning letter based on an injectables plant inspection in late February ...

Boehringer Ingelheim, Eli Lilly can resubmit NDA for diabetes drug with warning letter resolved

Eric Palmer Boehringer Ingelheim has finally received some good news for its manufacturing facility in Ingelheim, Germany. The FDA has notified it that it has closed out a warning ...

UPDATED: FDA panel says Aleve should keep its heart-risk warning

Eric Palmer Bayer's painkiller Aleve carries the same heart-risk warning as other nonsteroidal anti-inflammatories, or NSAIDs, like Motrin and Advil. And as far as an FDA review ...

J&J follows up on pledge to add warning to Tylenol bottle caps

Eric Palmer The FDA has pushed makers of the nonaspirin pain reliever acetaminophen to do more to warn consumers about the dangers of the drug when taken in high doses. J&J is now ...

FDA slams Wockhardt with warning letter on troubled plant

Tracy Staton Wockhardt said over the weekend that the FDA had issued a warning letter related to shortfalls at its facility in Waluj, India. Drugs made there had already barred from ...

Fresenius gets warning letter for India plant

Eric Palmer Fresenius Kabi, the generic drug unit for the German healthcare company, this week received an FDA warning letter for a plant in India. The company said it is dealing with ...

A Honey Of A Warning Letter, Or ‘Yes, The FDA Can Read Spanish’

esilverman When is a jar of honey really a drug? When the manufacturer promotes its sweet stuff for treating arthritis and allergies, at least as far as the FDA is concerned. ...

FDA warning letter cites Baxter for mold at plant, hair in infusion products

Eric Palmer The FDA has sent Baxter International a warning letter laying out problems it found during inspections at a plant in North Carolina as well as at a plant in Jayuya, Puerto ...

Boehringer Ingelheim handed FDA warning letter

Eric Palmer Boehringer Ingelheim, whose contract manufacturing facility in Bedford, Ohio, has been at the heart of huge drug disruptions in the U.S., is now feeling the sting of FDA ...
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