James L Dunnie

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Rockville MD 20857

Organizations: DHHS FDA ORA OGROP ORA OMPTO OPQO DPQP PQPB

Total Inspections: 12

Total 483s Issued: 6

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 5 days

Shortest Inspection: 1 days

Average Length of Inspection: 2.9 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2016-06-24Watson Pharma Private LimitedVernaIndia3005719315
2015-11-20AstraZeneca Dunkerque Production (AZDP)DordogneFrance3003063819
2015-11-13Altergon Italia SRLMorra De SanctisItaly3007086839
2015-11-06ACRAF SpA Aziende Chimiche Riunite Angelini FrancescoApriliaItaly3002806291
2015-04-23Alembic Pharmaceuticals Ltd (API Division, Karakhadi)VadodaraIndia3007501748
2015-04-17Glenmark Pharmaceuticals LimitedBharuchIndia3007514214
2015-04-10Torrent Pharmaceuticals LimitedBharuchIndia3010228235
2010-11-19Bayer Pharma AGBerlinGermany3002808086
2010-11-09Antibiotice S.A.JassiRomania3003489017
2009-09-17Arrow PharmBirzebuggiaMalta & Gozo3004971892

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Co-Inspectors

NameInspectionsLast Inspection
Michael E Maselli22010
Tina M Pawlowski22008

Active Locations

Year-wise Inspection Count