FDA Inspection 1312242 — Steribite, LLC
The FDA completed an inspection of Steribite, LLC on April 8, 2026 in Wooster, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 8, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wooster, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |
| 23036 | ISO 13485:2016 Clause 4.2.3 | Medical device file not established and maintained |
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23075 | ISO 13485:2016 Clause 6.2(e) | Records of personnel competence not maintained |
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23168 | ISO 13485:2016 Clause 7.5.6 | Planned results not consistently met during validation of processes |
| 23172 | ISO 13485:2016 Clause 7.5.6 | Computer software used in production and service provision not validated |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |