Devices

QS Violations Found at American Contract Systems

A 9/9-10/4 FDA inspection at the American Contract Systems medical device operations in Houston, TX, found Quality System Regulation violations in the firm’s work as a medical device manufacturer and contract sterilizer of various surgical trays/kits for hospital use. A just-released 11/9 Warning Letter lists specific violations as:

failing to adequately validate with a high degree of assurance a process whose results cannot be fully verified by subsequent inspection and test;
failing to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specific requirements continue to be met;
failing to document the review and evaluation of a process performed in response to changes or process deviations;
failing to adequately validate computer software as part of production for its intended use according to an established protocol; and
failing to adequately maintain device master records.

The letter says the agency did not receive the firm’s response to the inspection observations to determine if corrections and/or corrective actions had been implemented to address any of the violations.

American Contract was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, including documentation of the corrections and/or corrective actions and a timetable for completion of the steps.

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