# FDA 483 - MHC Medical Products LLC - September 23, 2022

Source: https://www.keypedia.com/records/483/mhc-medical-products-llc/7cd8a9f6-c229-4961-9de3-f5354e35344e

> FDA 483 for MHC Medical Products LLC on September 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MHC Medical Products LLC
- Inspection Date: 2022-09-23
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of MHC Medical Products LLC, a device specification developer in Fairfield, OH, revealed a significant issue with their design history files. The firm lacked proper documentation for the design of their safety pen needle, including design inputs, reviews, and verification/validation testing, as required by 21 CFR 820. These essential files, though reportedly maintained by a contract manufacturer, were not readily accessible or retrievable by MHC.

## Related Documents

- [483 - 2018-02-02](https://www.keypedia.com/records/483/mhc-medical-products-llc/f8c47890-895b-44c2-8176-8e3d1273ef2c)

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.keypedia.com/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

Company: https://www.keypedia.com/companies/mhc-medical-products-llc/b5427535-3cbf-4ea5-9811-b7ee07feb7a3

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22