Company
United StatesMichClone Associates, Inc., Troy, MI – FDA Inspections
Inspection records and compliance data for MichClone Associates, Inc. in Troy, Michigan. 6 FDA inspections on record, 1 Form 483, last inspected September 04, 2025.
Company Profile
This profile covers MichClone Associates, Inc. based in Troy, Michigan, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected July 2, 2010. Last inspected September 4, 2025.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- DHR content1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 4, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1281306 |
| December 17, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1158990 |
| March 9, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003228 |
| June 3, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 882137 |
| November 22, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 753208 |
| July 2, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 670119 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
MichClone Associates, Inc.
FEI Number
1831312
Address
1713 Larchwood Dr Ste B, Troy, Michigan 48083, United States
Country
United States
ID: 1f461019-66a8-4440-8d90-70db6682ed8b