FDA Inspection
OMNIlife Science, Inc.OMNIlife Science, Inc. – FDA Inspection, Aug 6, 2026
Record Details
This FDA Inspection record concerns OMNIlife Science, Inc., with an inspection on August 6, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · 80cf009f-40f1-4003-b68f-5ec54d8672cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1329750
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
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Other FDA inspections of OMNIlife Science, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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