Warning Letters

Latest Headlines

Latest Headlines

Dr. Reddy's gets slapped with FDA warning letter for three Indian plants

Dr. Reddy's has been investing in more automated plants in hopes of impressing the FDA and avoiding the kinds of regulatory actions that have sidelined competitors' plants. It didn't work out like the Indian drugmaker had hoped. Last week, the FDA sent the drugmaker a warning letter for three of its plants.

FDA savages U.S. acetaminophen, aspirin maker in warning letter

An Indiana aspirin and acetaminophen producer closed up production last year for lack of funds, but the FDA is making sure that it doesn't open back up again without meeting basic standards after the agency found it using slipshod manufacturing methods and producing OTC pain meds that failed to meet standards on just about every measure.

Novartis' Sandoz plants in India cited in warning letter

Novartis said on Tuesday in its earnings announcement that two Sandoz plants in India had been nailed last week with a warning letter. CEO Joseph Jimenez said the FDA issued the warning letter for the sites in Kalwe as well as one in Turbhe, a plant that Sandoz intends to close.

FDA issues Form 483 to compounder AmerisourceBergen is buying for $2.6B

The FDA issued a warning letter last year to PharMEDium Healthcare Holdings, the large compounding pharmacy operation that AmerisourceBergen said last week it would buy for $2.6 billion. But it turns out that FDA inspectors were back at the compounder's Cleveland center more recently and found that some problems with sanitation have yet to be resolved, while noting new issues.

UPDATED: Pfizer Chinese JV partner Zhejiang Hisun Pharma has products banned by FDA

The Chinese half of a Pfizer joint venture has found itself crosswise with the FDA, which has banned products from one of its plants and written it up in warning letter.

FDA castigates Indian drugmaker over mess at API plant

If the holes in the ceiling and walls allowing pigeons to fly around manufacturing equipment at India's Pan Drugs were not enough to warrant an FDA warning letter, then the fact that it also was not thoroughly testing its APIs did the trick.

FDA sears maker of GolfersSkin Sunscreen in warning letter

According to the marketing for GolfersSkin Sunscreen, more top players in the world trust it than any other. According to an FDA warning letter to its New Zealand manufacturer, they probably shouldn't.

UPDATED: FDA castigates three Mylan sterile drug plants in warning letter

Mylan's recent recall of injected cancer drugs, was a hint that all was not well at some of the plants Mylan got two years ago in its $1.75 billion deal for Indian sterile injectables producer Agila Specialties. But just how deep those problems are came to light today when the FDA posted a warning letter for three of those Indian facilities, including one that was cited shortly before Mylan bought it.

Indian drugmaker in hot water with FDA over forged records

FDA investigators found a record-keeping mess at an Indian drug manufacturer that they say raises concerns about the quality of the active pharmaceutical ingredients that it shipped for use in U.S. drugs.

FDA warning letter lays out cross-contamination issues at Canada plant

In April, Health Canada closed an active pharmaceutical ingredient repackager in Toronto and had it recall hundreds of bulk APIs that the regulators said could have been cross-contaminated by penicillin. Now the FDA has weighed in with a warning letter for the company.