Generic sterile injectables maker Claris Lifesciences has dug its way out from under a 2-year-old import alert having received the FDA's OK for plants in New Jersey and India.
In a closeout letter filed this week, the FDA says the Indian company has made the needed improvements in the plants where contamination problems led to the agency's warning and the ban on products from the plant in Ahmedabad, India.
The alert was imposed in June 2010, after reports that some of the company's products were contaminated with fungus. Pfizer ($PFE) was forced to recall some antibiotics and an anti-nausea product contracted out to Claris that were tied to the contamination issues.
The FDA said Claris had been told by Sagent Pharmaceuticals ($SGNT), 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. Pfizer reported similar problems.
The news lifted the company's shares nearly 20% in trading in India. The website Equity & Bulls says the company announced that the closeout letter had been posted but that it had not received an official notification from the FDA about its new standing.
- see the FDA closeout letter
- get the FDA warning letter
- read the Equity & Bulls report
Claris says it satisfied FDA in plant inspection, awaits final word
FDA blocks Claris imports on plant troubles
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