Devices

Multiple Types of Violations at Specialty Health Products

A 12/1-12/11/2025 FDA inspection at Specialty Health Products in Phoenix, AZ, found multiple violations in the firm’s illegal manufacturing of colonic irrigation systems and speculum kits. A just-released 7/7 Warning Letter lists these Quality System Regulation violations:

failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses, including testing of production units under actual or simulated use conditions;
failure to establish and maintain design change procedures;
failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
failure to establish and maintain procedures to control all documents that are required by regulations.

The letter also says FDA determined that the firm’s devices are adulterated because Specialty Health does not have an approved PMA or IDE in effect for the device as described and marketed. One of its devices is misbranded, it says, because the company placed it in commercial distribution with major changes or modifications to the intended use without submitting a new premarket application.

The devices are also misbranded, FDA says, because they don’t contain a required unique device identifier. The letter further describes registration and listing violations.

Specialty was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, 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