# FDA 483 - Titan Spine, LLC - December 11, 2017

Source: https://www.keypedia.com/records/483/titan-spine-llc/bfeba043-0a18-44c1-a12c-5cfe0e69a1da

> FDA 483 for Titan Spine, LLC on December 11, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Titan Spine, LLC
- Inspection Date: 2017-12-11
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Titan Spine, LLC, a medical device manufacturer in Milwaukee, WI, received an FDA Form 483 citing multiple quality system deficiencies. These included inadequate environmental controls and process validation for its clean room, and significant failures in its corrective and preventive action (CAPA) system. The firm also failed to adequately establish complaint handling procedures and did not submit Medical Device Reports (MDRs) within the required timeframes.

## Related Officers

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

Company: https://www.keypedia.com/companies/titan-spine-llc/6dfe9eb8-b338-4803-b1b0-f7b8beccf8b0

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