The QMN Weekly Bulletin

Quality System, CAPA Slipups Put Devicemakers Under FDA Microscope

Jan. 20, 2012

As devicemakers struggle to fine-tune corrective and preventive action (CAPA) procedures, many don’t make it and are snagged during FDA inspections.

Beckman Coulter recently got a warning letter for CAPAs that didn’t pinpoint the root causes of problems. And the company’s efforts to fix its procedures were deemed inadequate.

Lax CAPAs and quality foibles also brought unwanted attention to Precision Systems, which got an FDA Form 483 when inspectors found no formal quality policy on hand.

The company had no appointed quality representative, did not review the effectiveness of its quality system and had inadequate CAPA procedures.

Devicemakers — stop spinning your wheels with nonessential activities that waste time and money. To survive in today’s tough economy and ultra-competitive medical device market, you need a quality system that works from the get-go — from the start of product design continuing through component selection, manufacturing, use and disposal.

Don’t let poor CAPA procedures and other quality mistakes catch you off guard. Register now for Medical Device Quality & Compliance Institute 2012: Quality Systems and Design Control Training — two courses presented by EduQuest in cooperation with FDAnews that are offered separately or as an integrated three-and-a-half-day learning package —learn how to develop a by-the-book quality management program. Leave the guessing to your competitors!