Devices

QS, MDR Violations at S. Korea’s Aju Pharm

A 1/20-1/23 FDA inspection at Aju Pharm Co. Ltd. in Seongnam-Si, Gyeonggi, South Korea, found Quality System (QS) and Medical Device Reporting (MDR) violations in the company’s manufacturing of the Class 2 Fixone Hybrid Knotless Anchor and the Class 2 Fixone Biocomposite Anchor. A just-released 5/21 Warning Letter says the specific QS violations were:

failure to adequately establish procedures for validating the device design;
failure to adequately establish and maintain procedures for implementing corrective and preventive action;
failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
failure to adequately establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, where deviations from device specifications could occur because of the manufacturing process; and
failure to adequately establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur, the sampling plans are reviewed.

The inspection also determined that Aju failed to adequately develop, maintain, and implement written MDR procedures.

The letter says the firm’s responses to the QS observations were inadequate, while the adequacy of the MDR response could not be determined. FDA says it is detaining the firm’s products without inspection until the violations are addressed.

Aju was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

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