The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

Talk to Me Tech Gets Form 483 For Procedural Violations

Jan. 6, 2017

Talk to Me Technologies landed a Form 483 for not establishing corrective and preventive action procedures or performing quality audits.

According to an inspection conducted at the company’s Cedar Falls, Iowa, facility in October, it failed to establish procedures to describe methods for documenting corrective actions to quality system deviations.

The firm also failed establish an internal quality auditing procedure and conduct internal audits of its facility quality system.

You know your requirements for your supplier management program. But what does the FDA expect? Follow the five-step plan in QSR-Compliant Purchasing Controls to avoid becoming part of that statistic. This FDAnews Brief explains what the regulation requires and how to make sure your system passes muster.

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