FDA Inspection
Light Age, Inc.Light Age, Inc. – FDA Inspection, Sep 29, 2023
Record Details
This FDA Inspection record concerns Light Age, Inc., with an inspection on September 29, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b161d551-c870-4b0a-a48b-d9106fd81b5a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1219313
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Showing 10 of 14 citations.
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Other FDA inspections of Light Age, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 11, 2020 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 17, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 20, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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