Company
United StatesSpacelabs Healthcare, Inc., Snoqualmie, WA – FDA Inspections
Inspection records and compliance data for Spacelabs Healthcare, Inc. in Snoqualmie, Washington. 8 FDA inspections on record (1 OAI), 2 Form 483s, last inspected September 15, 2022.
Company Profile
This profile covers Spacelabs Healthcare, Inc. based in Snoqualmie, Washington, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 4
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected March 12, 2010. Last inspected September 15, 2022.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Not approved or obsolete document retrieval2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 15, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1179915 |
| September 7, 2018 | Not classified | Medical Devices & Rad Health | 1123931 |
| June 1, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1056344 |
| March 9, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1003822 |
| July 31, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 942482 |
| April 2, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 872781 |
| April 18, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 777613 |
| March 12, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 652281 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Spacelabs Healthcare, Inc.
FEI Number
3010157426
Address
35301 Se Center St, Snoqualmie, Washington 98065, United States
Country
United States
ID: b4938dc5-6f3f-4f5b-b42e-fef42d06c0e9