Greenwald Surgical Company Falls Short on Nonconformance Documentation

Device manufacturer Greenwald Surgical landed an FDA Form 483 for failing to document rework and reevaluation activities for its surgical products following a March 2018 inspection of its Lake Station, Indiana facility revealed.

The maker of urological and electrosurgical instruments and accessories failed to document nonconforming subassemblies used in manufacturing finished products as nonconforming and instead reworked them without documentation or evaluation, the agency said.

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 repairing the product was not documented as rework.

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