Devices

Quality System, Other Violations at Forcemech

A 3/28-4/4 FDA inspection at Forcemech International, Pearland, TX, determined that the firm is a manufacturer (repackager/relabeler) and initial distributor/importer of the Forcemech Navigator and Navigator XL powered wheelchairs. A 9/21 Warning Letter says the devices are adulterated due to Quality System Regulation violations. Specific violations cited were:

failing to adequately maintain a device master record to include, or refer to the location of, the packaging and label specifications, including methods and processes used;
failing to establish and maintain procedures to control labeling activities;
failing to adequately establish procedures for acceptance activities;
failing to adequately establish and maintain document control procedures; and
failing to adequately establish procedures for performing service activities and verifying that servicing meets specified requirements.

FDA also says the firm’s wheelchairs are misbranded in that it failed to have on the device label or labeling information that is required by law. The devices also are misbranded because the firm failed to furnish material or information required by law respecting the device. The letter says Forcemech failed to ensure that the label of every medical device bears a unique device identifier and failed to provide required information to the Global Unique Device Identification Database.

The firm was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to accomplish this, plus an explanation of how it plans to prevent these or similar violations in the future, with documentation of the corrections and a schedule for completing them.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome