Dorothy W Lee
FDA Investigator Report
Designation: SUPERVISORY CONSUMER SAFETY
Duty Station: Rockville MD 20857
Organizations: DHHS FDA ORA OGROP ORA OMPTO OMDRHO
Total Inspections: 18
Total 483s Issued: 17
Total Warning Letters Issued: 6
Inspection Details
Longest Inspection: 5 days
Shortest Inspection: 2 days
Average Length of Inspection: 1.6 days
Discover the bigger picture. This is just the tip of the iceberg.
Gain access to comprehensive analysis, detailed reports, AI assistant, and much more.
Schedule a DemoRecent Inspections
Date | Company | City | Country | FEI Number | 483 |
---|
2015-03-31 | Cepheid Ab | Solna | Sweden | 3009613136 | |
2015-03-26 | Bioprod D.O.O. | Ljubljana | Slovenia | 3010084488 | |
2014-04-10 | DiaSorin Ireland Ltd. | Dublin | Ireland | 3002806536 | |
2014-03-31 | Medinol Ltd. | Tel Aviv | Israel | 3003084171 | |
2014-03-27 | Medinol Ltd. | Jerusalem | Israel | 3003182398 | |
2014-02-20 | Creganna Medical Pte Ltd | Singapore | Singapore | 3008950987 | |
2014-02-12 | I-Sens, Inc. | Seoul | Korea (the Republic of) | 3005621222 | |
2013-04-23 | VARITEKS ORTOPEDI SAN. A.S. | Zeytinburnu | Turkey | 3009303371 | |
2013-04-17 | Vision RT Ltd | London | United Kingdom | 3004832819 | |
2013-01-30 | Catalent Belgium SA | Brussels | Belgium | 3007647000 | |
Co-Inspectors
Active Locations
- Austria
- Israel
- Hungary
- Ireland
- Korea, Republic Of (South)
- Sweden
- Turkey
- Slovenia
- Korea (the Republic of)
- Estonia
- Germany
- Australia
- Singapore
- United Kingdom
- Belgium
- Japan
Year-wise Inspection Count
- 2010: 2 inspections
- 2011: 1 inspections
- 2012: 5 inspections
- 2013: 3 inspections
- 2014: 5 inspections
- 2015: 2 inspections