Integra Closes Second of Three Warning Letters

Integra LifeSciences has resolved the second of three warning letters it received over 15 months, announcing a closeout letter from the FDA for its Anasco, Puerto Rico, facility.

The Anasco plant, which had been under a quality-related warning letter since Feb. 13, 2013, was cleared Jan. 14, based on a September 2014 inspection.

The other closeout letter was given to Integra’s Plainsboro, N.J., facility on Sept. 24, 2014. The remaining warning letter is for an Andover, UK, plant that the company is closing. Company officials do not expect to resolve that letter before the closure.

Wells Fargo analyst Larry Beigelsen says the Anasco closeout “removes a slight overhang,” but is unlikely to have a significant impact on earnings. “We believe that the Street largely expected the closeout of the Anasco warning letter and the timing is consistent with the message of IART management over the past year,” he writes.

The Anasco warning letter cited Integra for shortfalls in complaint investigations and reviews, and for failing to identify corrective actions. In the Plainsboro letter, the investigator noted mold in an equipment room, unclear environmental control procedures and failure to adequately complete cleaning validation processes.

Integra CEO Peter Arduini says the company has “made significant investments in both people and processes” over the last several years to boost its global quality assurance programs. “The lifting of the warning letter at our Anasco facility is evidence of the progress we have made.”

The remaining warning letter, for the Andover plant, relates to corrective and prevention actions, process validation, and quality audits and reviews.

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