# Steribite, LLC – FDA 483, Apr 8, 2026

Source: https://www.keypedia.com/records/483/steribite-llc/3f8c174f-4da2-49b7-b265-4fcf39fe0121

> FDA 483 for Steribite, LLC on April 08, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steribite, LLC
- Inspection Date: 2026-04-08
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Steribite, LLC, a medical device manufacturer in Wooster, OH, received 12 observations during an FDA inspection, highlighting significant deficiencies across its quality management system. The firm failed to adequately document design and development procedures, validate critical manufacturing processes, control nonconforming products, and manage outsourced activities. These issues indicate a broad lack of adherence to regulatory requirements for medical device production.

## Related Officers

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

Company: https://www.keypedia.com/companies/steribite-llc/9b9712b0-a831-486e-8b41-08f75e3b85d7

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