Claris closeout letter ends product ban tied to contamination

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

Related Articles: 
Claris says it satisfied FDA in plant inspection, awaits final word
FDA blocks Claris imports on plant troubles

Like what you're reading?
Click here to get more news delivered to your inbox everyweek>>

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.