# FDA 483 - Multisource Manufacturing LLC - November 08, 2017

Source: https://www.keypedia.com/records/483/multisource-manufacturing-llc/61af7e4e-17b9-4b80-aed3-cf920e06fd9f

> FDA 483 for Multisource Manufacturing LLC on November 08, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Multisource Manufacturing LLC
- Inspection Date: 2017-11-08
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of MultiSource Manufacturing LLC in Lafayette, CO, a medical device manufacturer, revealed three significant observations. The firm was cited for failing to adequately validate automated manufacturing processes, establish proper procedures for in-process product acceptance and control, and implement sufficient corrective and preventive action procedures. These issues indicate deficiencies in the firm's quality management system.

## Related Officers

- [Kathleen S. Tormey](https://www.keypedia.com/people/kathleen-s-tormey/5e1abfe2-078a-4c61-bb98-3885f853a945)

Company: https://www.keypedia.com/companies/multisource-manufacturing-llc/e197c51a-737d-47b0-92d5-4bed43e65cfe

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face