FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Surgical Instruments Maker Racks Up 11-item 483

Dec. 19, 2018
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Lax medical device reporting and CAPA procedures as well as a host of other quality issues were uncovered during a July 31 to Aug. 2 FDA inspection of LED Intellectual Properties’ Irvine, Calif. facility.

Corrective and preventive action SOPs were found lacking because procedures didn’t define requirements for dealing with existing or potential quality problems, the 11-item 483 said.  The FDA inspector noted that the firm’s CAPA procedures didn’t require investigation to identify the underlying causes of potential problems.

The firm had no documentation for CAPA activities and complaints weren’t handled in a timely manner.

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