Devices

Multiple Violations in Unapproved Wintech Medipro Masks

A 6/22-7/6/22 FDA inspection at Wintech Medipro in Katy, TX, found multiple violations in the firm’s manufacturing of surgical masks for which it does not have an approved PMA or IDE in place. A just-released 11/16/22 Warning Letter says the masks have been distributed in the U.S. without marketing approval, clearance, or authorization from FDA. The devices also are misbranded because Wintech failed to notify FDA of its intent to introduce them into commercial distribution.

The letter says the devices are further misbranded because Wintech has not established procedures for timely and effective identification, communication, and evaluation of reportable events; a standardized review process for determining when an event meets reportability criteria; timely submission of Medical Device Reports to FDA; or for compliance with the applicable documentation and recordkeeping requirements.

FDA also identified these Quality System regulation violations:

failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
failing to establish procedures to validate a process whose results cannot be fully verified by subsequent inspection and test;
failing to establish and maintain procedures for corrective and preventive actions;
failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to establish and maintain procedures to control product that does not conform to specified requirements;
failing to establish and maintain procedures for acceptance activities such as inspections, tests, or other verification activities;
failing to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements; and
failing to establish procedures for quality audits and to conduct such audits.

Wintech was told to take prompt actions to address the violations and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with documentation of the corrective actions and a schedule for completing the corrections.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

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