FDA Inspection
Equilibrated Bio SystemsEquilibrated Bio Systems – FDA Inspection, Mar 2, 2010
Record Details
This FDA Inspection record concerns Equilibrated Bio Systems, with an inspection on March 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Equilibrated Bio Systems
- Inspection Date
- March 2, 2010
- Product Type
- Devices
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ID · 6f34c01c-586f-4bdd-8706-7302e37e3dca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 649615
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Equilibrated Bio Systems
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 2, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 14, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Equilibrated Bio Systems
- FDA Inspection 1157607 - 2021-11-16
- FDA Inspection 1068444 - 2018-10-02
- FDA Inspection 935577 - 2015-07-23
- FDA Inspection 813887 - 2013-01-14
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