A U.S. distributor's report to manufacturer Claris Lifesciences of a "swirling mass" in IV bags of antibiotic Metronidazole has culminated in an FDA warning letter. CEO Arjun Handa received the missive at his office in Ahmedabad, India, early this month.
The distributor, Sagent Pharmaceuticals, identified the swirling mass as a Cladosporium fungus. The FDA says in the warning that inspectors found no signs of a Claris root cause investigation until April 26, 2010--nearly two weeks after the distributor's complaint. And before another two weeks had passed, Sagent reported to Claris that another lot of Metronidazole was contaminated, this time with Mucor species fungi.
The Claris investigation comes up short in identifying the cause for both contamination incidents, the warning says. Claris focused on IV bag integrity--it disregarded Sagent's finding that the contamination was present in bags having no leaks because it objected to the distributor's method of leak detection.
But that misses the point, the warning implies, because the real issue is the source of the unwanted fungi. The FDA finds also that Claris investigated only bags returned by Sagent, including no other bags from the lot.
The agency instructs Claris to explain why it waited nearly two weeks to begin its investigation. It asks for details of the final investigation and corrective actions, as well as an explanation of the company's current leak-detection process.
- see Warning Letter 320-11-003