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483
•Millstone Medical Outsourcing, LLC•October 22, 2021

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

Record Details

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.

Company
Millstone Medical Outsourcing, LLC
Inspection date
October 22, 2021
Product type
device
Office
Division of Northeast Imports 
Person
  • John A. Sciacchitano (investigator)
View Company Profile

ID · b7c00d80-ff2f-4163-b4b8-5b7e40a1548c

Other documents for Millstone Medical Outsourcing, LLC
  • 483 - 2024-12-18December 18, 2024

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