Warning Letters

Latest Headlines

Latest Headlines

FDA hands Wockhardt and Ipca more disappointing news

It has been another tough week for some of India's troubled drugmakers. Wockhardt, which has two plants banned by the FDA, saw its hopes stymied for getting export approval for a different facility that it had hoped could help it recoup some of its lost U.S. revenues. And India's Ipca Laboratories, which has three plants on the import alert list, said Monday it has now gotten a warning letter for the facilities.

FDA slams another Chinese drugmaker with a warning letter

The FDA has again found a lot that it doesn't like about a Chinese drugmaker. The agency has followed up an import alert against Chan Yat Hing Medicine Factory's drugs and cosmetic products with a warning letter.

Sun Pharma smacked by FDA warning letter for leaky ceiling, contamination risks

The FDA indicated in a warning letter this week that Sun Pharmaceutical has some gaps in its manufacturing processes at its Halol plant, as well as leaks in the ceiling, that put its drugs at risk for contamination.

FDA issues import alert on Pan Pharma, ramping up its pressure on the India drugmaker

The FDA has followed up a warning letter it issued to Pan Pharmaceuticals with an import alert that effectively extends a ban on the drugmaker's products in the U.S.

FDA warning letter blasts Dr. Reddy's for undisclosed testing

When Dr. Reddy's acknowledged last month that it had received a warning letter for three of its Indian plants, it proclaimed it was "actively engaged" with the FDA to resolve the issues. But an FDA warning letter posted last week says that even after the company responded 9 times to the host of observations, the agency has not been assured it is on top of serious problems which included the discovery of a previously undisclosed testing lab.

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.