483
Team Innovations Inc.Team Innovations Inc. – FDA 483, May 7, 2019
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.
View Company Profile
ID · 39dba522-6f9a-4c66-9b20-e2c9e3ed7551
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.