FDA Inspection
Spacelabs Healthcare, Inc.Spacelabs Healthcare, Inc. – FDA Inspection, Mar 9, 2017
Record Details
This FDA Inspection record concerns Spacelabs Healthcare, Inc., with an inspection on March 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Cynthia L. Gorveatt (Issuing Officer)
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ID · e7f76d55-0f88-454a-a5a2-57efde5ecff1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003822
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Spacelabs Healthcare, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 7, 2018 | Not classified | Seattle District Office | |
| June 1, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 2, 2014 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spacelabs Healthcare, Inc.
- FDA Inspection 1179915 - 2022-09-15
- FDA Inspection 1123931 - 2018-09-07
- FDA Inspection 1056344 - 2018-06-01
- FDA Inspection 942482 - 2015-07-31
- FDA Inspection 872781 - 2014-04-02
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