# FDA 483 - Millstone Medical Outsourcing, LLC - December 18, 2024

Source: https://www.keypedia.com/records/483/millstone-medical-outsourcing-llc/6d541a47-2629-40a9-b1e4-2bc8869a531e

> FDA 483 for Millstone Medical Outsourcing, LLC on December 18, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Millstone Medical Outsourcing, LLC
- Inspection Date: 2024-12-18
- Product Type: device
- Office Name: New England District Office
- Summary: Millstone Medical Outsourcing, LLC in Fall River, MA, a medical device manufacturer, was cited for inadequate process validation during an FDA inspection. Specifically, their heat process for device cartons was not qualified, leading to undefined parameters and a lack of documentation for the number of passes through the oven tunnel. This deficiency resulted in multiple complaints of melted or warped medical device trays.

## Related Documents

- [483 - 2021-10-22](https://www.keypedia.com/records/483/millstone-medical-outsourcing-llc/b7c00d80-ff2f-4163-b4b8-5b7e40a1548c)

## Related Officers

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

Company: https://www.keypedia.com/companies/millstone-medical-outsourcing-llc/08e76d52-ab4a-4542-8824-8cd10e553379

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144