FDA Inspection
Ingenious Technologies Corp.Ingenious Technologies Corp. – FDA Inspection, Jun 12, 2012
Record Details
This FDA Inspection record concerns Ingenious Technologies Corp., with an inspection on June 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ingenious Technologies Corp.
- Inspection Date
- June 12, 2012
- Product Type
- Devices
View Company Profile
ID · 77767c2e-4679-4383-996b-ded5e5331a63
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 786147
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ingenious Technologies Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 9, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ingenious Technologies Corp.
- FDA Inspection 1092789 - 2019-06-10
- FDA Inspection 941419 - 2015-09-09
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