# FDA 483 - Tangible Solutions, Inc. DBA Marle Tangible, Inc. - October 05, 2022

Source: https://www.keypedia.com/records/483/tangible-solutions-inc-dba-marle-tangible-inc/297ebd84-5b2d-43c8-b739-0c1826792d1e

> FDA 483 for Tangible Solutions, Inc. DBA Marle Tangible, Inc. on October 05, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tangible Solutions, Inc. DBA Marle Tangible, Inc.
- Inspection Date: 2022-10-05
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Tangible Solutions, Inc. DBA Marle Tangible, Inc., a medical device manufacturer in Fairborn, OH, revealed significant deficiencies in their quality system. Observations included inadequate process validation for cleaning lines, insufficient supplier approval procedures, and a lack of control and monitoring over production processes. These issues indicate a need for comprehensive corrective actions to ensure product quality and regulatory compliance.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.keypedia.com/companies/tangible-solutions-inc-dba-marle-tangible-inc/d3c6ef48-58c4-4225-9120-4293dbff6546

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22