# FDA 483 - Realized Mfg LLC - August 27, 2025

Source: https://www.keypedia.com/records/483/realized-mfg-llc/18ccfa72-945f-448a-b303-052fd7d29d18

> FDA 483 for Realized Mfg LLC on August 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Realized Mfg LLC
- Inspection Date: 2025-08-27
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Realized Mfg LLC, a medical device manufacturer in Medina, OH, was inspected and cited for significant quality system deficiencies. Observations included inadequate procedures for corrective and preventative actions, insufficient process validation for manufacturing and cleaning, and a failure to ensure all monitoring equipment is routinely calibrated and maintained. These issues indicate a lack of robust quality control over critical manufacturing processes and device quality.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.keypedia.com/companies/realized-mfg-llc/f2c4edf7-cf88-47be-8dfb-7612f62e8d60

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