Company
United StatesSpectranetics Corporation, Fremont, CA – FDA Inspections
Inspection records and compliance data for Spectranetics Corporation in Fremont, California. 4 FDA inspections on record, last inspected September 17, 2020.
Company Profile
This profile covers Spectranetics Corporation based in Fremont, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected December 9, 2015. Last inspected September 17, 2020.
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 17, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1131615 |
| February 14, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1082312 |
| January 13, 2017 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 1002459 |
| December 9, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 973395 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Spectranetics Corporation
FEI Number
3009784280
Address
6531 Dumbarton Cir, Fremont, California 94555, United States
Country
United States
ID: e52bc819-1a32-4409-91c3-1a9a5919e5f7