FDA Inspection
Sunburst EMS, Inc.Sunburst EMS, Inc. – FDA Inspection, Aug 26, 2015
Record Details
This FDA Inspection record concerns Sunburst EMS, Inc., with an inspection on August 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunburst EMS, Inc.
- Inspection Date
- August 26, 2015
- Product Type
- Devices
View Company Profile
ID · 862966df-57cc-4f63-9903-e48952b59765
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943387
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sunburst EMS, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sunburst EMS, Inc.
- FDA Inspection 785159 - 2012-06-06
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