# FDA 483 - Prentke Romich Company DBA PRC-Saltillo - May 01, 2025

Source: https://www.globalkeysolutions.net/records/483/prentke-romich-company-dba-prc-saltillo/24bb5c12-a782-4dbf-ae3c-a7d97dc270e8

> FDA 483 for Prentke Romich Company DBA PRC-Saltillo on May 01, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prentke Romich Company DBA PRC-Saltillo
- Inspection Date: 2025-05-01
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Prentke Romich Company DBA PRC-Saltillo, a manufacturer of augmentative alternative communication devices in Wooster, OH, was inspected and received five observations. The inspection revealed significant deficiencies in software validation, documentation of field corrections, corrective and preventive actions, complaint handling procedures, and device history records. These issues indicate a moderate level of non-compliance with quality system regulations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.globalkeysolutions.net/companies/prentke-romich-company-dba-prc-saltillo/bf155ced-53bb-41e3-9409-c14b0aa3a078

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