FDA Inspection
Lumasense Technologies, Inc.Lumasense Technologies, Inc. – FDA Inspection, Apr 16, 2010
Record Details
This FDA Inspection record concerns Lumasense Technologies, Inc., with an inspection on April 16, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lumasense Technologies, Inc.
- Inspection Date
- April 16, 2010
- Product Type
- Devices
View Company Profile
ID · f4c0fc06-69fa-4152-946a-d75c3c070e4e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 660358
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Lumasense Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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