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Mold Contamination in Claris IV Bags Results in Class I Recalls, Warning Letter and Import Alert

Nov 30th, 2010

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The findings of fungal contamination in IV bags contract-manufactured at Claris Lifesciences’ Ahmedabad, India facility has resulted in a three-product Class I recall, an FDA warning letter and a U.S. import alert on Claris products.

Issued at the beginning of November, the warning letter from Center for Drug Evaluation and Research (CDER) Compliance Office Director Deborah Autor to Claris CEO Arjun Handa lays out the course of events that surrounded the contamination findings and details why the firm’s response was inadequate.

The warning letter sheds light on what is expected when quality problems surface in marketed products and, in particular, on the agency’s increasing concern with quality oversight in contract manufacturing. FDA’s compliance and field offices have made clear both from the podium and in inspections and follow-up warning letters that contractor/sponsor relationships are high on the agency’s radar screen (IPQ “In the News” June 18, October 6, October 16, and October 28).

The Claris case also underscores the frequently-voiced affirmation that under Commissioner Margaret Hamburg’s watch FDA’s enforcement response will be swift and vigorous when public health is judged at risk.

Mold contamination was also a central issue in a warning letter issued by FDA’s Compliance Office two days earlier to Wrexham, U.K.-based CP Pharmaceuticals (see IPQ “In the News” November 30 companion story).

The two letters highlight the attention being given by FDA investigators to contamination control in sterile product manufacturing facilities located abroad and where the red flags lie.

[More on the compliance issues raised at Claris and how they fit in with FDA’s enforcement priorities is provided for subscribers beginning on page 2.  Non-subscribers may purchase the full story along with the CP companion story for $75 by contacting Wayne Rhodes at [email protected]. To subscribe to IPQ, click here.]

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