FDA Inspection
ELITechGroup, Inc.ELITechGroup, Inc. – FDA Inspection, Aug 11, 2017
Record Details
This FDA Inspection record concerns ELITechGroup, Inc., with an inspection on August 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dcfe5642-67db-4c25-8b1f-558a86553ebe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021632
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.170(b)Installer records
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Other FDA inspections of ELITechGroup, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 1, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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