FDA Inspection
Nano-Ditech CorporationNano-Ditech Corporation – FDA Inspection, Jun 3, 2014
Record Details
This FDA Inspection record concerns Nano-Ditech Corporation, with an inspection on June 3, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nano-Ditech Corporation
- Inspection Date
- June 3, 2014
- Product Type
- Devices
View Company Profile
ID · f782b26c-6c42-4ad8-b35a-68fc00d79353
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 882198
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nano-Ditech Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2026 | Not classified | New Jersey District Office | |
| September 19, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 29, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 15, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 7, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nano-Ditech Corporation
- FDA Inspection 1313410 - 2026-04-06
- FDA Inspection 1218856 - 2023-09-19
- FDA Inspection 1063763 - 2018-06-29
- FDA Inspection 922362 - 2015-04-15
- FDA Inspection 574528 - 2009-04-07
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