FDA Inspection
Light Age, Inc.Light Age, Inc. – FDA Inspection, Mar 11, 2020
Record Details
This FDA Inspection record concerns Light Age, Inc., with an inspection on March 11, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Light Age, Inc.
- Inspection Date
- March 11, 2020
- Product Type
- Devices
View Company Profile
ID · a7445f8c-7baf-46b4-b7be-fd36120d1139
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1120786
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Light Age, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 1, 2022 | VAI | 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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