The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

Greenwald Surgical Issued Form 483 for Lack of Documentation

July 13, 2018
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Greenwald Surgical landed a Form 483 for failing to document rework and reevaluation activities for its surgical products.

A March 2018 inspection of its Lake Station, Indiana facility revealed that the maker of urological and electrosurgical instruments and accessories didn’t document nonconforming subassemblies used in manufacturing finished products as nonconforming, and instead reworked them without documentation or evaluation, according to the Form 483.

Assembly operators told FDA inspectors that flexible endoscopic electrodes that failed an in-process inspection were repaired and retested, but the nonconforming product was not documented as nonconforming and the process of repairing the product was not documented as rework, the agency said.

The FDA also found fault with the firm’s device acceptance procedures because they did not ensure that acceptance activities required by the device master record were completed.

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