Company
United StatesSpectranetics Corporation, Fremont, CA – FDA Inspections
Inspection records and compliance data for Spectranetics Corporation in Fremont, California. 5 FDA inspections on record, last inspected January 13, 2016.
Company Profile
This profile covers Spectranetics Corporation based in Fremont, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 14, 2009. Last inspected January 13, 2016.
Most cited issue areas
- CAPA verification/validation of corrective/preventive action1 inspection
- Identification procedures, Lack of or inadequate procedures1 inspection
- Investigation of device failures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 13, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 970688 |
| June 12, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 835940 |
| March 1, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 711052 |
| March 12, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 653454 |
| January 14, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 571186 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Spectranetics Corporation
FEI Number
3005462046
Address
5055 Brandin Ct, Fremont, California 94538, United States
Country
United States
ID: 2393106d-d23e-4224-969a-691e7896d200