# FDA 483 - SunMed Holdings, LLC - August 30, 2023

Source: https://www.globalkeysolutions.net/records/483/sunmed-holdings-llc/a2380278-c228-4a93-b6ef-beab336da704

> FDA 483 for SunMed Holdings, LLC on August 30, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SunMed Holdings, LLC
- Inspection Date: 2023-08-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of SunMed Holdings, LLC in Grand Rapids, MI, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, control nonconforming products, and conduct proper risk analyses for their AirFlow Manual Resuscitator/Ventilators, which were found to exceed ISO standards for dead space. These issues raise concerns about the safety and effectiveness of their medical devices.

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.globalkeysolutions.net/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)
- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/sunmed-holdings-llc/dbb11583-1848-42f3-8615-d25909c59304

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