Devices

QS, Other Violations at Zyno Medical

A 1/29-2/15 FDA inspection at Zyno Medical, Natick, MA, found Quality System Regulation violations in the firm’s manufacturing of infusion pumps and associated administration sets. A just-released 7/12 Warning Letter says specific violations were:

failing to adequately establish and maintain procedures for implementing corrective and preventive action;
failing to adequately establish and maintain procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes before their implementation; and
failing to adequately review, evaluate, and investigate any complaint involving the possible failure of a device to meet any of its specifications, unless such investigation has already been performed and another investigation is not necessary.

FDA says the adequacy of the firm’s responses to its inspection observations cannot be determined at this time.

The inspection also determined that the firm’s administrative sets are misbranded because Zyno failed or refused to furnish material or information required under the Medical Device Reporting regulation.

The inspection further determined that the administrative sets are adulterated because Zyno does not have an approved PMA or IND application in effect.

Zyno was told to respond with a list of specific steps it has taken to address the noted violations and an explanation of how it intends to prevent these or similar violations from recurring, with documentation of the corrections or corrective actions, and a timetable 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

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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