Devices

QS Violations Found at E-Care Technology

A 10/22-10/25/19 FDA inspection at E-Care Technology, Chubei City, Taiwan, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of the Swaive thermometer. A just-released 3/2 Warning Letter says specific violations were:

failing to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses, including testing of production units under actual or simulated use conditions;
failing to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purpose and is capable of producing valid results;
failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
failing to establish and maintain procedures to ensure that sampling methods are adequate for the company’s intended use and to ensure that when changes occur the sampling plans are reviewed.

The letter says the firm’s responses to the inspection observations were all inadequate.

The inspection also determined that the firm’s devices were misbranded because E-Care failed or refused to furnish Medical Device Reporting information by failing to develop, maintain, and implement written Medical Device Reporting procedures. The response to that observation also was inadequate, FDA says.

FDA says it is detaining without inspection the Swaive thermometer until the violations are corrected. E-Care was told to respond with a list of specific actions taken to correct the violations and prevent their recurrence, with documentation of each action, and a timetable for completing the work.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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