# FDA 483 - Single Source Medical LLC. - December 06, 2023

Source: https://www.keypedia.com/records/483/single-source-medical-llc/e9beaf13-ce54-47c7-a1d9-ccbbe77282c8

> FDA 483 for Single Source Medical LLC. on December 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Single Source Medical LLC.
- Inspection Date: 2023-12-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Single Source Medical LLC. in North Liberty, IN, a medical device manufacturer, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, insufficient monitoring of a validated passivation process, failures in acceptance activities, and deficiencies in complaint handling procedures. These issues indicate a systemic breakdown in maintaining quality control and compliance with established procedures.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/single-source-medical-llc/c7b34837-c424-4f31-8a55-82c2d5222952

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0