FDA Inspection
MichClone Associates, Inc.MichClone Associates, Inc. – FDA Inspection, Jul 2, 2010
Record Details
This FDA Inspection record concerns MichClone Associates, Inc., with an inspection on July 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MichClone Associates, Inc.
- Inspection Date
- July 2, 2010
- Product Type
- Devices
View Company Profile
ID · b3f40c11-f379-4dbb-9a93-363da392b382
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 670119
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| March 9, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 |
Other documents for MichClone Associates, Inc.
- FDA Inspection 1281306 - 2025-09-04
- FDA Inspection 1158990 - 2021-12-17
- FDA Inspection 1003228 - 2017-03-09
- FDA Inspection 882137 - 2014-06-03
- FDA Inspection 753208 - 2011-11-22
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.