Devices

Envoy Medical QS Violations

A 6/24-7/2 FDA inspection at Envoy Medical in Saint Paul, MN, found Quality System regulation violations in the firm’s manufacturing of the Esteem II implantable hearing system. A just-released 11/11 Warning Letter says the specific violations were:

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 for corrective and preventive action; and
failure to adequately establish and maintain design validation procedures to ensure proper risk analysis is completed.

The letter says the company’s responses to the inspection observations were not adequate. Envoy was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

“The specific violations noted in this letter and in the inspection observations, form FDA-483, issued at the close of the inspection may be symptomatic of serious problems in your manufacturing and quality management systems,” FDA concludes. “Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.”

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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