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www.fdanews.com/articles/11389-fda-flags-procedural-failures-reporting-issues-at-trimed

FDA Flags Procedural Failures, Reporting Issues at Trimed

March 17, 2017

The FDA issued a Form 483 to Trimed, citing procedural failures, as well as labeling and reporting problems.

In a March 2016 inspection of the medical device manufacturer’s Santa Clarita, California, facility, the inspector noted the firm failed to properly evaluate complaints of possible device failures, and did not submit an MDR report within 30 days of being informed of risks of a malfunction — a repeat observation dating back to a 2012 inspection.

Read the Trimed Form 483 here: www.fdanews.com/03-17-17-trimedinc483.pdf.