FDA Inspection
Lumicell, Inc.Lumicell, Inc. – FDA Inspection, Aug 18, 2023
Record Details
This FDA Inspection record concerns Lumicell, Inc., with an inspection on August 18, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ee5eb780-4d2c-4200-b170-e087d2e9cc86
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215178
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
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Other FDA inspections of Lumicell, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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