March 11, 2019 / 10:36 AM / 6 months ago

Integra gets FDA warning letter for Boston plant

March 11 (Reuters) - 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 here in a regulatory statement.

Sales of products manufactured in the Boston facility made up less than 4 percent of the company’s revenue in 2018, Integra said. (Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shounak Dasgupta)

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