Company
United StatesLightScalpel, Inc., Bothell, WA – FDA Inspections
Inspection records and compliance data for LightScalpel, Inc. in Bothell, Washington. 5 FDA inspections on record, last inspected December 02, 2022.
Company Profile
This profile covers LightScalpel, Inc. based in Bothell, Washington, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected January 24, 2012. Last inspected December 2, 2022.
Most cited issue areas
- Design history file1 inspection
- Design review - documentation1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 2, 2022 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1192349 |
| March 13, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1083043 |
| June 29, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 976441 |
| February 27, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 868843 |
| January 24, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 765194 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
LightScalpel, Inc.
FEI Number
3008720474
Address
11818 N Creek Pkwy N Ste 100, Bothell, Washington 98011, United States
Country
United States
ID: f91f6b0d-bad8-4578-9dcc-d4fb4191a6be