Devices

Multiple Violations in ZIIP Inspection

A 1/5-1/12 FDA inspection at ZIIP, Inc. in Pleasant Hill, CA, determined that the firm manufactures the ZIIP HALO device and the HALO 2.0, ZIIP DOT, and ZIIP Gels. A just-released 5/22 Warning Letter says all of the devices other than the original ZIIP HALO are adulterated and misbranded because the company does not have an approved PMA or IDE in effect for them and did not notify FDA of its intent to enter them into commercial distribution.

The letter also lists these Quality System violations:

failure to ensure that design verification confirmed that design outputs meet design input requirements;
failure to adequately establish and maintain procedures for design validation, including adequate risk analysis;
failure to adequately establish and maintain procedures for corrective and preventive action;
failure to adequately establish and maintain procedures for design changes; and
failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.

FDA requested that ZIIP immediately cease any activities that result in the misbranding or adulteration of the devices, such as the commercial distribution of the devices for the uses described in the letter.

ZIIP was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of each action and a schedule for completing the corrections.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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