Team Innovations Inc.May 7, 2019

FDA 483 - Team Innovations Inc. - May 07, 2019

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Record Details

An FDA inspection of Team Innovations Inc., a medical device manufacturer in Waukesha, WI, revealed two significant observations. The firm was cited for lacking valid statistical rationale for sampling plans used in functional testing of its CenterRidge Hollow Snap electrodes. Additionally, the inspection found that a device master record for the CenterRidge Hollow Snap electrode had not been adequately maintained.

Company: Team Innovations Inc.
Inspection Date: May 7, 2019
Product Type: Device
Office: Minneapolis District Office
Person: Michelle J. Glembin (investigator)

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ID · 39dba522-6f9a-4c66-9b20-e2c9e3ed7551