The QMN Weekly Bulletin

Whitehall Manufacturing Draws FDA Warning for Therapy Devices

Aug. 4, 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.

The investigator also noted that Whitehall management executives had failed to conduct adequate and timely product quality reviews. Management also failed to identify training needs and provide appropriate training for their employees. The company failed to report problems with malfunctioning devices within 30 calendar days as required by CFR 803.50(a)(2) if the malfunction would be likely to cause or contribute to a death or serious injury.

Whitehall responded to the FDA notification of violations on April 13, submitting updated complaint handling procedures and other requested information, but the response was deemed inadequate by the agency.

Whitehall also submitted a medical device reporting procedure for their devices as required, but the FDA found the submitted procedure did not establish effective internal procedures for reporting problems.

The July 12 warning letter specifically addresses cases in which the dry heat therapy device and the hydrotherapy device failed and were replaced without documentation. In one case, the customer reported that a hydrotherapy device smelled like it was burning. In another case, a customer reported a defective turbine; the company replaced the turbine and brought the defective one back for testing, but did not document any subsequent test results. In yet another case, a defective splint pan therapy device, used to soften and custom shape splint material, caused the water temperature in the device to rise above the boiling point, but no investigation was documented.

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