FDA Inspection
MichClone Associates, Inc.MichClone Associates, Inc. – FDA Inspection, Mar 9, 2017
Record Details
This FDA Inspection record concerns MichClone Associates, Inc., with an inspection on March 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Amy S. Graf (Issuing Officer)
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ID · 95896daf-3a8d-48c2-90ce-38d0e0c189e6
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1003228
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.22Quality audits - auditor independence
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Other FDA inspections of MichClone Associates, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 17, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 3, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 22, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 2, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for MichClone Associates, Inc.
- FDA Inspection 1281306 - 2025-09-04
- FDA Inspection 1158990 - 2021-12-17
- FDA Inspection 882137 - 2014-06-03
- FDA Inspection 753208 - 2011-11-22
- FDA Inspection 670119 - 2010-07-02
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