Company
United StatesKaren K. Winer, M.D., Rockville, MD – FDA Inspections
Inspection records and compliance data for Karen K. Winer, M.D. in Rockville, Maryland. 2 FDA inspections on record (1 OAI), last inspected October 26, 2011.
Company Profile
This profile covers Karen K. Winer, M.D. based in Rockville, Maryland, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 3, 2010. Last inspected October 26, 2011.
Most cited issue areas
- Consent form not approved/signed/dated1 inspection
- Ensuring compliance with plan and protocol1 inspection
- FD-1572, protocol compliance1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 26, 2011 | NAI | Human Drugs · Bioresearch Monitoring | 751446 |
| February 3, 2010 | OAI | Human Drugs · Bioresearch Monitoring | 646330 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Karen K. Winer, M.D.
FEI Number
3007623714
Address
6100 Executive Blvd Rm 4B-11, Rockville, Maryland 20852, United States
Country
United States
ID: 29291739-aa7e-40f3-9820-f2232a356f98