Company
United StatesMark E. Kutner, MD, Miami, FL – FDA Inspections
Inspection records and compliance data for Mark E. Kutner, MD in Miami, Florida. 5 FDA inspections on record, last inspected March 10, 2020.
Company Profile
This profile covers Mark E. Kutner, MD based in Miami, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 27, 2010. Last inspected March 10, 2020.
Most cited issue areas
- FD-1572, protocol compliance3 inspections
- Case history records- inadequate or inadequate2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 10, 2020 | NAI | Human Drugs · Bioresearch Monitoring | 1121105 |
| May 15, 2015 | VAI | Biologics · Bioresearch Monitoring | 927639 |
| August 28, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 899328 |
| August 24, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 796321 |
| October 27, 2010 | VAI | Human Drugs · Bioresearch Monitoring | 685673 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Mark E. Kutner, MD
FEI Number
3008311325
Address
Suncoast Research Group, Llc, 2128 W Flagler St Ste 101, Miami, Florida 33135, United States
Country
United States
ID: b85a53f8-1d68-4032-9262-f745c5e13e74