Claris imports banned after company investigates IV bag integrity, not fungus within
Drug supplier Claris Lifesciences is banned from importing products to the US from its flagship Indian plant for a series of unaddressed good manufacturing practice violations that led to contaminated IV bags, and complaints from US distributors and consumers. Some of the unaddressed issues that led to the ban suggest earlier or expanded involvement by regulators could help resolve safety issues more quickly than the company is on track to do on its own.
In June, remember, the company recalled a number of its IV antibiotics and anti-nausea drugs made in the Claris factory in India after some medications tested positive for Cladosporium fungus. At that time, the FDA warned providers not to use IV medications made by Claris, as the fungus could harm immuno-compromised patients.
This month’s letter criticizes the company for delayed and improper investigation that failed to pinpoint the root cause of the fungal contamination in its IV medications–even though the fungal matter was visible. From the FDA warning letter:
On May 31, 2010, your customer (Pfizer) reported that Metronidazole Injection USP IV bags (lot A090722) were contaminated with fungi (Cladosporium species) and Gram positive bacteria (Brevibacterium casei). Pfizer returned 33 unopened Metronidazole Injection USP bags, but your Complaint Investigation Report failed to identify the contaminants that Pfizer visually observed in at least 31 of these bags.According to InPharm, the company makes “a broad range of sterile injectable products including the antibiotics ciprofloxacin, metronidazole and levofloxacin, antifungal fluconazole and anti-nausea drug ondansetron.”
Inspection and GMP issues are not solved overnight, but the Claris letter is disturbing because it underscores the company’s failure to
a) keep equipment clean in order to prevent contamination b) start the investigation in a timely manner c) find the contamination source, focusing instead on the integrity of the IV bags themselves, not the fungal matter d) tell their distributors and customers about the reported contamination, as the FDA indicates here they are required to do:
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’s own label. Your responsibility as a contract manufacturer is to inform all of your customers of a significant production problem or possible product hazard immediately.When it comes to contamination and good manufacturing practices, there’s been some high-profile foot-dragging on the part of drug companies and suppliers, especially in telling the public and downstream members of the supply chain. The Claris case, then, is one more reason to expand the FDA’s authority to remove risky or unsafe products from US shelves when contamination is identified, rather than waiting months and months for a company to handle—or fail to handle—the issues on its own.
You can read more about the June recall and about proposals to expand FDA recall authority and reform supply chain oversight here.
–Kate Petersen, PostScript blogger