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.
The FDA has issued a warning letter to a Chinese plant that makes active pharmaceutical ingredients for having suspect testing data after finding a failed test result in the trash and discovering the computer record of it had been overwritten. The letter comes as the agency is working to get more inspectors into the country, which has become the go-to producer of cheap APIs for the global market.
When India's Cadila Pharmaceuticals got complaints from customers about some of its APIs smelling bad, the drugmaker decided the odor stemmed from an impurity, so it tweaked the manufacturing process. The problem, according to the FDA, is that the plant never conducted an investigation to determine whether the impurity was in fact the cause, so the company never knew whether it had really resolved the cause of the stench.
Hikma recently acknowledged that it had received a warning letter from the FDA for a plant in Portugal. What the drugmaker did not disclose is that some of the warnings were repeats, noted in three previous inspections of the facility dating back a decade.
Hikma Pharmaceuticals got a closeout notice in March for a warning letter that had been hanging over its West-Ward plant in New Jersey. But at nearly the same time, inspectors were looking over a Hikma facility in Portugal, and the Jordan-based company says the FDA has now issued a warning letter for its sterile injectables plant there.