FDA Inspection
Zeus Scientific, Inc.Zeus Scientific, Inc. – FDA Inspection, Feb 19, 2016
Record Details
This FDA Inspection record concerns Zeus Scientific, Inc., with an inspection on February 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zeus Scientific, Inc.
- Inspection Date
- February 19, 2016
- Product Type
- Devices
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ID · 6429b9fd-9477-40ae-9f5d-b14674645d10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 964811
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.103(a)IRB review requirement
- 21 CFR 809.10(c)(2)(ii)Not exempt--lacks For Investigational Use statement
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zeus Scientific, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 7, 2018 | Not classified | New Jersey District Office | |
| May 3, 2017 | Not classified | New Jersey District Office | |
| May 31, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 27, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zeus Scientific, Inc.
- FDA Inspection 1133551 - 2020-08-31
- FDA Inspection 1065350 - 2018-06-07
- FDA Inspection 1020402 - 2017-05-03
- FDA Inspection 785399 - 2012-05-31
- FDA Inspection 584558 - 2009-05-27
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