# FDA 483 - Liberty Engineering Inc - December 18, 2019

Source: https://www.keypedia.com/records/483/liberty-engineering-inc/4afc42f8-a0f4-44e2-b831-9c154696bce6

> FDA 483 for Liberty Engineering Inc on December 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Liberty Engineering Inc
- Inspection Date: 2019-12-18
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Liberty Engineering Inc, a medical device manufacturer in Newton, MA, was inspected by the FDA from December 12-18, 2019. The inspection revealed multiple significant deficiencies in their quality system, including inadequate equipment calibration, undocumented supplier evaluations, insufficient in-process testing documentation, lack of rework procedures, undocumented personnel training, and poorly maintained device history records. These issues indicate a failure to adhere to established quality system regulations for medical devices.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/liberty-engineering-inc/1071260f-f98f-4e6c-bcbc-e863e30d79bf

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94