Devices

14 Observations in Zimmer Biomet Inspection

A 10-week FDA inspection at Zimmer Biomet from 9/12/16 to 11/22/16 led to a 58-page FDA-483 detailing 14 inspection observations, some of which were repeated from earlier inspections. The just-released document shows these violations:

failing to adequately validate according to established procedures a process whose results cannot be fully verified by subsequent inspection and test, repeated from a 2014 inspection;
failing to adequately establish procedures to control environmental conditions;
failing to adequately establish procedures to control product that does not conform to specified requirements;
failing to establish procedures for design control;
failing to adequately establish procedures for corrective and preventive action;
failing to adequately establish process control procedures that describe any process controls necessary to ensure conformance to specifications;
failing to adequately establish procedures for monitoring and control of process parameters for a validated process, repeated from a 2014 inspection;
failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to adequately establish procedures for acceptance activities;
failing to have buildings of suitable design to perform necessary operations;
failing to have sampling plans based on valid statistical rationale;
failing to adequately establish procedures for rework of nonconforming product;
failing to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements; and
failing to adequately establish document control procedures.

The document says the company promised to correct all of the observations.

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