Company
United StatesSpectranetics Corporation, Colorado Springs, CO – FDA Inspections
Inspection records and compliance data for Spectranetics Corporation in Colorado Springs, Colorado. 7 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 01, 2019.
Company Profile
This profile covers Spectranetics Corporation based in Colorado Springs, Colorado, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 1
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected February 26, 2009. Last inspected March 1, 2019.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 1, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1083024 |
| September 27, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1026732 |
| January 21, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 956408 |
| March 14, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 825660 |
| November 16, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 754488 |
| November 5, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 696646 |
| February 26, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 569907 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Spectranetics Corporation
FEI Number
3007284006
Address
9965 Federal Dr, Colorado Springs, Colorado 80921, United States
Country
United States
ID: 335746a0-8bce-4c14-bf46-8e1930329c2e