FDA Inspection
Spacelabs Healthcare, Inc.Spacelabs Healthcare, Inc. – FDA Inspection, Jul 31, 2015
Record Details
This FDA Inspection record concerns Spacelabs Healthcare, Inc., with an inspection on July 31, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spacelabs Healthcare, Inc.
- Inspection Date
- July 31, 2015
- Product Type
- Devices
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ID · e9f58a94-1b91-4144-a69b-d0f4c5a94573
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 942482
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
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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 |
| March 9, 2017 | VAI | Center for Devices and Radiological Health | Compliance: 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 1003822 - 2017-03-09
- FDA Inspection 872781 - 2014-04-02
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