FDA Inspection
Steribite, LLCSteribite, LLC – FDA Inspection, Apr 8, 2026
Record Details
This FDA Inspection record concerns Steribite, LLC, with an inspection on April 8, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · 43fa79d2-5eaa-4149-a08f-4a5bf488dbf3
Inspection Facts
- Inspection number
- 1312242
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
- ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
- ISO 13485:2016 Clause 5.6.1QMS not reviewed by top management at documented planned intervals
- ISO 13485:2016 Clause 6.2(e)Records of personnel competence not maintained
- ISO 13485:2016 Clause 7.1Processes needed for product realization not planned and developed
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 7.5.6Computer software used in production and service provision not validated
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Other FDA inspections of Steribite, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Steribite, LLC
- FDA Inspection 1040314 - 2017-12-21
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