|
 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.
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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.
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