# FDA 483 - Millstone Medical Outsourcing, LLC - October 22, 2021

Source: https://www.globalkeysolutions.net/records/483/millstone-medical-outsourcing-llc/b7c00d80-ff2f-4163-b4b8-5b7e40a1548c

> FDA 483 for Millstone Medical Outsourcing, LLC on October 22, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Millstone Medical Outsourcing, LLC
- Inspection Date: 2021-10-22
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Millstone Medical Outsourcing, LLC in Fall River, MA, was inspected from October 5-22, 2021. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to adequately establish and utilize CAPAs for recurring problems with its automated cleaning systems and to verify the effectiveness of corrective actions.

## Related Documents

- [483 - 2024-12-18](https://www.globalkeysolutions.net/records/483/millstone-medical-outsourcing-llc/6d541a47-2629-40a9-b1e4-2bc8869a531e)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7