SOPs, instructions noted in Henley warning letter.

Henley Healthcare, which manufactures the Fluidotherapy device, pulled in a 13-page warning letter that cited validation issues, such as failure to "establish and maintain documented instructions, SOPs and methods."

For example, the Sept. 20 letter cited the case of a handwritten assembly procedure that was "neither legible nor readable." The same assembly procedure also was cited for changes instituted "without management review and approval."

The letter, triggered by a February-March inspection of Henley's Sugar Land, TX, facility, said there were several complaints of device malfunction that should have been filed under MDR rules, but which Henley did not file with FDA.

In one instance, a foam component caught fire when it contacted a heating device within the unit. The second event involved "a short circuit and spark/flame" in another model "which was determined to have been caused by long metal bolts that protruded into the inner housing, causing the housing to contact the electrical connectors for the heater."

FDA deemed the firm's corrective action in the matter of the long bolt invalid, the warning letter indicated.

Henley responded to the 483/EIR by noting "approval signatures" and "retrospective validation [which] is supported by the functional performance of the units." FDA called the response inadequate because the "letter does not indicate any documented verification or validation activities."

Temperature not defined, validated

Another item said Henley failed to "develop, conduct, control and monitor production processes," in reference to "the specified time interval for the Fluidotherapy device to reach a specified temperature has not been defined and validated."

The letter also insisted that Henley failed to "establish procedures to assure finished devices meet all acceptance activities before distribution." In this instance, the device history record did not document the final acceptance status of traction machines.

Henley's documentation also failed to note "actual temperature before and after calibration, specific calibration dates and calibration due dates" for dial thermometers, FDA said. The company could not be reached for comment. Doc. 8186W.