Company
United StatesSpentech, Inc., Redmond, WA – FDA Inspections
Inspection records and compliance data for Spentech, Inc. in Redmond, Washington. 5 FDA inspections on record, last inspected July 27, 2017.
Company Profile
This profile covers Spentech, Inc. based in Redmond, Washington, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected August 26, 2009. Last inspected July 27, 2017.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 27, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1020883 |
| February 4, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 912557 |
| March 19, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 821840 |
| July 21, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 735761 |
| August 26, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 608313 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Spentech, Inc.
FEI Number
3003139439
Address
14907 NE 95th St, Redmond, Washington 98052, United States
Country
United States
ID: 720f7c67-477b-4f8d-b8cc-ba3b46c1104c