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Medical Devices / Inspections and Audits

Micro Current Technology Called Out for Inadequate Procedures

May 17, 2018

Micro Current Technology drew a Form 483 from the FDA over the lack of procedures for design changes and reworking nonconforming product.

The Seattle, Washington firm failed to use an engineering change order to document and approve design changes, having no ECO to document and approve changes made to a device label.

In addition, one of the firm’s non-conforming material procedures lacked details for performing a rework of a nonconforming product.

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