Devices

Multiple Violations at ELITech Netherlands Facility

A 3/27-3/30 FDA inspection at the ELITech Group facility in Spankeren, The Netherlands, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of the Selectra Pro S, Selectra Pro M, and Viva Junior analyzer devices. Specific violations cited in a just-released 9/20 Warning Letter were:

failing to adequately establish and maintain procedures for corrective and preventive action (CAPA) activities and failing to adequately document CAPA results;
failing to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints;
failing to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure;
failing to adequately establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
failing to adequately establish and maintain procedures for acceptance of incoming product, to be adequately inspected or tested to verify conformance to specification;
failing to adequately establish and maintain procedures for installation and inspection instructions and, where appropriate, test procedures;
failing to adequately establish and maintain procedures for quality audits;
failing to adequately develop and maintain written Medical Device Reporting procedures; and
failing to submit any report required within 10 working days of initiating a correction or removal.

FDA says the firm’s responses to the inspection observations were inadequate or their adequacy could not be determined. The company was told to respond with a list of specific steps it has 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

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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