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

Source: https://www.globalkeysolutions.net/records/483/team-innovations-inc/39dba522-6f9a-4c66-9b20-e2c9e3ed7551

> FDA 483 for Team Innovations Inc. on May 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Team Innovations Inc.
- Inspection Date: 2019-05-07
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.globalkeysolutions.net/companies/team-innovations-inc/444af7f6-c154-456c-b878-4a0de641db9a

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d