Devices

QS Issues Found in Tianjin Bolang Science Tech. Inspection

A 3/22-3/30 FDA inspection at Tianjin Bolang Science Technology Development Company, Tianjin Shi, China, found Quality System Regulation issues in the firm’s manufacturing of otoscopes, rigid laryngoscopes, and rigid nasopharyngoscopes. A just-released 6/17 Warning Letter says specific violations were:

failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
failing to establish and maintain procedures for implementing corrective and preventive action;
failing to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution;
failing to maintain device master records and to ensure that each such record is prepared and approved according to regulations;
failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured following the device master record and regulatory requirements;
failing to maintain a quality system record that includes or refers to the location of, procedures, and the documentation of activities required by regulations that are not specific to a particular type of device; and
failing to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by regulations are correctly performed; and
failing to develop, maintain, and implement medical device reporting procedures.

The letter says the firm’s responses to most of the issues were inadequate, with the adequacy of the remaining responses unable to be determined.

FDA says it is taking steps to refuse the entry of the firm’s devices into the U.S. until the violations are corrected. The firm was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation for each correction or corrective action and a timetable for completing the work.

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