FDAnews Device Daily Bulletin

Whitehall Manufacturing Draws FDA Warning for Therapy Devices

Aug. 3, 2017

Whitehall Manufacturing received a warning letter for multiple violations concerning its whirlpool immersion hydrotherapy and dry heat therapy devices.

Whitehall, a division of Acorn Engineering Company located in the City of Industry, Calif., produces healthcare and rehabilitation equipment, including physical therapy and sports medicine products.

An FDA investigator inspected the facility on March 6-23 and found numerous violations, including failure to establish a designated unit with formal procedures for receiving and evaluating consumer complaints; failure to investigate the possible failure of a device; and failure to establish a design history file or maintain a device history record.

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