FDAnews Device Daily Bulletin

Southeastern Technology Gets 483 for Personnel Training

July 28, 2017

Following an FDA inspection, Southeastern Technology was cited for its process control procedures and personnel training.

In an April inspection of the firm’s Murfreesboro, Tenn., facility, the FDA faulted the devicemaker on its process controls for the cleaning line as identified by its SOPs. Investigators interviewed a cleaning line operator and a regulatory compliance manager and found the facility did not use its conductivity meter to verify cleaning solution concentration, even though the company’s cleaning tank solution test log was fully filled out.

The FDA also noted that the facility did not maintain documented personnel training records.

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