(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 flags issues related to its quality systems, the company said https://bit.ly/2SY0Uwi.
Sales of products manufactured in the Boston facility made up less than 4 percent of the company’s revenue in 2018, Integra said, adding that it does not expect to incur material incremental expense related resolving the issues.
FDA certificates needed for other countries and pre-market approvals for some devices, necessary for life support, will not be issued till the issues have been resolved, the company said.
The FDA’s letter does not restrict the company’s ability to manufacture or ship nor does it require a recall of its products, Integra said.
The company said the letter did not identify any new issues that were not already provided in a Form 483 notice that was issued after the Boston facility inspection.
On finding issues upon inspection of company facilities, the agency issues a Form 483, which if not resolved can lead to a “warning letter” and in worst case, a ban.
The company said it is in the process of preparing a written response to the letter.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shounak Dasgupta)