A Blow to Integra: FDA Warning Letter for Boston Plant

03 Apr 2019

A well-known medical devices maker Integra Lifesciences Holding Corporation got a warning letter from the U.S. Food and Drug Administration (FDA) regarding its manufacturing facility in Boston after an inspection held in October and November last year. The FDA issued flags related to quality system. A huge blow faced by the company as sales of the products manufactured made less than 4% of the company’s revenue in 2018 in Boston facility. The letter of FDA does not restrict the company to manufacture or ship nor required to recall its products. On finding issues upon inspection of the company’s facilities, the FDA agencies issued a Forum 483 which the company did not resolve. And hence, it leaded to a warning letter. The company is in the process of preparing a return response to the letter.

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