FDA Inspection
LightScalpel, Inc.LightScalpel, Inc. – FDA Inspection, Jun 29, 2016
Record Details
This FDA Inspection record concerns LightScalpel, Inc., with an inspection on June 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LightScalpel, Inc.
- Inspection Date
- June 29, 2016
- Product Type
- Devices
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ID · b99113f1-e995-4f37-a2c1-6406091432b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976441
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LightScalpel, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2022 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 13, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 24, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LightScalpel, Inc.
- FDA Inspection 1192349 - 2022-12-02
- FDA Inspection 1083043 - 2019-03-13
- FDA Inspection 868843 - 2014-02-27
- FDA Inspection 765194 - 2012-01-24
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