Carla J Lundi
FDA Investigator Report
Designation: CONSUMER SAFETY OFFICER
Duty Station: Silver Spring MD 20705
Organizations: DHHS FDA CDER OMPT CDER OPQ OS DQSA IAB
Total Inspections: 141
Total 483s Issued: 81
Total Warning Letters Issued: 6
Inspection Details
Longest Inspection: 38 days
Shortest Inspection: 1 days
Average Length of Inspection: 3.9 days
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Schedule a DemoRecent Inspections
Date | Company | City | Country | FEI Number | 483 |
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2021-07-02 | Revance Therapeutics Inc | Newark | United States | 3007772056 | |
2021-07-01 | Revance Therapeutics Inc | Moffett Field | United States | 3019604545 | |
2017-09-22 | Bioreliance Ltd. | Glasgow | United Kingdom | 3005343934 | |
2017-09-15 | NAMSA | Chasse Sur Rhone | France | 3004495705 | |
2017-09-12 | Novartis Pharma S.A.S. - Centre de Biotechnologie | Huningue | France | 3004864869 | |
2017-03-03 | Janssen Sciences Ireland UC | Ringaskiddy | Ireland | 3007029098 | |
2017-02-24 | Microchem Laboratories (Ireland) Ltd | Dungarvan | Ireland | 3002807550 | |
2017-02-17 | MedImmune U.K. Limited | Liverpool | United Kingdom | 3004066112 | |
2016-06-24 | Abraxis Bioscience, LLC | Phoenix | United States | 3006441852 | |
2016-05-11 | B. Braun Medical Inc | Irvine | United States | 2021236 | |
Co-Inspectors
Active Locations
- United States
- France
- Italy
- Ireland
- United Kingdom
- Canada
- India
- Denmark
- Sweden
- Austria
- Germany
- Switzerland
Year-wise Inspection Count
- 2008: 41 inspections
- 2009: 13 inspections
- 2010: 12 inspections
- 2011: 12 inspections
- 2012: 14 inspections
- 2013: 12 inspections
- 2014: 10 inspections
- 2015: 13 inspections
- 2016: 6 inspections
- 2017: 6 inspections
- 2021: 2 inspections