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.
The FDA issued an import alert in April banning all human and veterinary antibiotics and other drugs coming out of a plant in the Czech Republic. A warning letter the FDA posted this week to its website explains why. Vuab Pharma was shipping active pharmaceutical ingredients (APIs) to the U.S. that were contaminated with bacteria and didn't even have tests that were capable of detecting it.
The Business Standard of India reports plans by Claris Lifesciences to sell its generic sterile injectables business may be thwarted by an adverse observation letter the company is reported to have gotten from the FDA.
The FDA may be having difficulty getting inspectors stationed in China, but that has not stopped it from issuing warning letters to drug and ingredient makers there who have issues. The agency posted a second warning letter today for API maker Yunnan Hande Bio-Tech, which was previously cited in 2010.
Hospira has just picked up an FDA warning letter for a plant in Italy, meaning it now has plants tagged with warning letters on four of the 7 continents: Europe, North America, Asia and Australia. But the problem will be Pfizer's to deal with since it has struck a $15 billion deal to buy the sterile injectable specialist.
It has been more than a year and a half since the FDA issued a warning letter for two plants in India owned by Aarti Drugs. But the drugmaker has yet to meet FDA expectations and so the agency has now put them on an import alert, banning them from shipping products to the U.S.
The opening of Hospira's new plant in India that it is counting on to lower its manufacturing costs will be delayed again after it racked up another set of observations during a reinspection by the FDA last month. Unless quickly resolved, it will be an issue that Pfizer will inherit given its $15 billion buyout of Hospira announced last month.
FDA inspectors returned to a Wockhardt plant in Waluj that it banned in 2013 and weren't impressed by what they found during the weeklong inspection. New concerns were raised.