FDA Inspection
ELITechGroup, Inc.ELITechGroup, Inc. – FDA Inspection, Jul 22, 2011
Record Details
This FDA Inspection record concerns ELITechGroup, Inc., with an inspection on July 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ELITechGroup, Inc.
- Inspection Date
- July 22, 2011
- Product Type
- Devices
View Company Profile
ID · cd0f7a3c-7bbc-4652-b8d6-acb36fec2c24
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737028
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(c)Design input - review and approval
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(e)Design review - documentation
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Other FDA inspections of ELITechGroup, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 27, 2015 | 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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