FDA Inspection
Stellartech Research CorporationStellartech Research Corporation – FDA Inspection, Nov 9, 2010
Record Details
This FDA Inspection record concerns Stellartech Research Corporation, with an inspection on November 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 9, 2010
- Product Type
- Devices
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ID · 58135511-45a7-4e06-a0f9-f657d6f1a55d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 696963
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stellartech Research Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 29, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 12, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 20, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 14, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Stellartech Research Corporation
- FDA Inspection 1268787 - 2025-04-23
- FDA Inspection 1202527 - 2023-03-29
- FDA Inspection 1076850 - 2018-12-12
- FDA Inspection 939415 - 2015-08-20
- FDA Inspection 892384 - 2014-08-14
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