FDA Inspection
LightScalpel, Inc.LightScalpel, Inc. – FDA Inspection, Feb 27, 2014
Record Details
This FDA Inspection record concerns LightScalpel, Inc., with an inspection on February 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LightScalpel, Inc.
- Inspection Date
- February 27, 2014
- Product Type
- Devices
View Company Profile
ID · 7c6e7b6e-07d1-4d11-a9cc-e96e9ade15f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868843
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50(b)Supplier notification of changes
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 |
| June 29, 2016 | 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 976441 - 2016-06-29
- FDA Inspection 765194 - 2012-01-24
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