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.
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 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.
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.
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.
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.
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.
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.
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.
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.