FDA Inspection
Lumen Photon Therapy Inc.Lumen Photon Therapy Inc. – FDA Inspection, Apr 17, 2012
Record Details
This FDA Inspection record concerns Lumen Photon Therapy Inc., with an inspection on April 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lumen Photon Therapy Inc.
- Inspection Date
- April 17, 2012
- Product Type
- Devices
View Company Profile
ID · 87b31a03-24df-49db-9226-a20860d36e4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780575
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Lumen Photon Therapy Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lumen Photon Therapy Inc.
- FDA Inspection 1023339 - 2017-07-13
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