FDA Inspection
Lumasense Technologies, Inc.Lumasense Technologies, Inc. – FDA Inspection, Aug 28, 2013
Record Details
This FDA Inspection record concerns Lumasense Technologies, Inc., with an inspection on August 28, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lumasense Technologies, Inc.
- Inspection Date
- August 28, 2013
- Product Type
- Devices
View Company Profile
ID · 58eec2c7-fe3d-40c2-9fb5-29d5080c3211
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 847589
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Lumasense Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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