Natus Resumes Production and Shipping Operations at Olympic Facility

Natus Medical has resumed all production and shipping operations at its Olympic Medical manufacturing facility in Seattle after responding to issues raised in an FDA warning letter.

Natus received the warning letter Oct. 15 for violations related to process deficiencies at the Olympic facility.

The company voluntarily shut down operations at the facility Nov. 1 to address the findings identified by the FDA, Natus said. In a letter to the FDA dated Nov. 27, Natus fully responded to the issues raised in the warning letter.

Natus President and CEO Jim Hawkins said that after a complete review of all processes and procedures at the facility, along with training of personnel, the company is confident that Olympic is in compliance with FDA requirements and has resumed production and shipments at the facility.