Integra Lifesciences Boston plant gets USFDA warning letter

The warning letter was issued after an inspection held at the facility in October and November last year, and does not restrict the company's ability to manufacture or ship products nor does it require a recall of its products, Integra Lifesciences said in a regulatory statement.

U.S: Medical device maker Integra Lifesciences Holdings Corp said on Monday it had received a warning letter from the U.S. Food and Drug Administration regarding its manufacturing facility in Boston.

The warning letter was issued after an inspection held at the facility in October and November last year, and does not restrict the company's ability to manufacture or ship products nor does it require a recall of its products, the company said in a regulatory statement.

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Sales of products manufactured in the Boston facility made up less than 4 per cent of the company's revenue in 2018, Integra said.

Founded in 1989 Integra is headquartered in Plainsboro, The firm offers solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery.

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