FDA slaps import ban on Claris Life Sciences
pharmafile | November 16, 2010 | News story | Manufacturing and Production |Â Â Ahmedabad, Claris Life Sciences, FDA, GMP, GMP violations, Good Manufacturing Practice, Ranbaxy Pharmaceuticals, manufacturing complianceÂ
Indian drugmaker Claris Life Sciences has been prohibited from importing products into the US after manufacturing quality problems emerged at its main manufacturing plant, according to the FDA.
Claris, which manufactures products for a number of pharmaceutical customers on a contract basis, was sent a warning letter by the FDA on 1 November citing violations of Good Manufacturing Practice (GMP) at its facility in Ahmedabad, India.
A similar prohibition was levied on Ranbaxy Pharmaceuticals after the FDA found quality problems at two of its Indian plants more than two years ago, and is still in place today.
A June 2010 inspection of the Indian plant revealed a series of GMP violations, including failure to follow-up batch failures and file field alert reports (FARs) to the FDA.
Claris India acts as a contract manufacturer for IV bag products marketed by other firms, as well as a distributor of some batches under Claris’ own label. It makes a broad range of sterile injectable products including the antibiotics ciprofloxacin, metronidazole and levofloxacin, antifungal fluconazole and anti-nausea drug ondansetron.
Meanwhile an inspection of a Claris facility in New Jersey, USA, concluded the company was marketing an unapproved medicine (sodium bicarbonate injection) in the US.
Claris received complaints from customers about intravenous bags contaminated with fungus and bacteria, for example a metronidazole product which was found to by a customer (Pfizer) as well as a US distributor (Sagent Pharmaceuticals) to be contaminated with a Cladosporium fungal species.
The warning letter gives Claris the statutory 15-day period to respond, and indicates that Claris will not be able to sell products made at the Ahmedabad plant in the US until the FDA has verified that the facility is back in compliance with GMP.
Phil Taylor
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