Devices

QS Violations in Talon Inspection

A 3/11-3/28 FDA inspection at Talon, an S&S Technology company, in Houston, TX, found Quality System Regulations violations, including several repeated from a 2011 inspection, in the firm’s manufacturing of Class 1 and 2 medical equipment, healthcare supplies, and radiation products used for general and plastic surgery. An 8/2 Warning Letter says specific violations were:

failing to document corrective and preventive action activities and/or results;
failing to establish procedures for design change;
failing to adequately establish procedures to control product that does not conform to specified requirements;
failing to adequately maintain a device history record;
failing to document acceptance or rejection of incoming product;
failing to establish procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements;
failing to adequately establish records of acceptable suppliers, contractors, and consultants;
failing to have management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency;
failing to perform quality audits at defined intervals and at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures;
failing to adequately establish procedures for training and identifying training needs; and
failing to adequately maintain records of changes to documents.

The letter says several of the observations were repeated from a 2011 inspection. And it says that the firm’s responses to the 2019 inspection observations were all inadequate.

The FDA investigator also observed that Talon manufactures software-controlled medication cabinets and carts used for security and convenient access to medications and medical supplies. It says the software should be registered and listed under the appropriate regulation.

The letter further says that the software literature asserts that the software has been FDA approved. But, it says, the agency was unable to locate any information demonstrating that the firm has listed its MedKey Lite software with FDA.

Talon was told to take prompt action to correct the violations addressed in the letter and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step and a timetable for completion.

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