# FDA 483 - E-Beam Services Inc - September 26, 2023

Source: https://www.keypedia.com/records/483/e-beam-services-inc/360515c5-3c0f-4ce6-96c4-5fd5a1d13a93

> FDA 483 for E-Beam Services Inc on September 26, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: E-Beam Services Inc
- Inspection Date: 2023-09-26
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of E-Beam Services Inc in Lebanon, OH, from September 20-26, 2023, revealed a significant issue with process validation. The firm failed to adequately validate processes, specifically lacking documentation for performance qualification (PQ) activities for medical device products undergoing sterilization, as required by their own established procedures.

## Related Officers

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

Company: https://www.keypedia.com/companies/e-beam-services-inc/99b448ed-c901-4649-a523-88c025982feb

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