After two years of having products blocked by the FDA, Claris Lifesciences says it believes it has met FDA expecations and is awaiting word on whether it will again be able to ship to the U.S. from a plant in India.
In a report on its first-quarter results, the maker of generic injectable sterile drugs said it had "satisfactorily completed" an FDA audit. The plant was put on an FDA alert in June 2010, after reports that some of its products were contaminated with fungus. Pfizer ($PFE) was forced to recall some antibiotics and an antinausea product contracted out to Claris that were tied to the contamination issues.
In a warning letter sent later that year, the FDA said Claris had been told by Sargent Pharmaceutical, a U.S. distributor, that some of its sterile products "were contaminated with a swirling mass, which the complainant identified as the fungus Cladosporium." The FDA said Claris failed to get to the "root cause" of the problem. Similar problems were reported by Pfizer. FDA inspectors found issues at both the plant in Ahmedabad, India, and a plant in New Brunswick, NJ.
The FDA has stepped up inspections of foreign plants in recent years and issued import alerts where it deems necessary. Ranbaxy Laboratories, India's largest generics-maker, only this year began shipping products to the U.S. from one of its largest plants after a four-year blackout. Problems with Ranbaxy were so severe that in January, Ranbaxy, which is owned by Daiichi Sankyo in Japan, signed a consent decree with the Department of Justice with input from the FDA.
- read The Economic Times story
- the Claris report to shareholders (PDF)
- the FDA warning letter