Olga Simakova

FDA Investigator Report

Designation: BIOLOGIST

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CBER CBER OBRR DHRR LPD

Total Inspections: 6

Total 483s Issued: 6

Total Warning Letters Issued: 0

Inspection Details

Longest Inspection: 17 days

Shortest Inspection: 4 days

Average Length of Inspection: 9.8 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-08-23Merck Sharp & Dohme LLCWest PointUnited States2510592
2023-09-19Octapharma ABStockholmSweden3005559915
2023-03-02Kamada - Production PlantMP NegevIsrael1000630279
2019-09-12Grifols Biologicals LLCCity Of IndustryUnited States2077802
2019-09-12Grifols Biologicals LLCLos AngelesUnited States2080769
2018-11-16Kedrion Biopharma Inc.MelvilleUnited States3003683714

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Download 483s and EIRs for Olga Simakova

Co-Inspectors

NameInspectionsLast Inspection
Nobuko H Katagiri22019
Malgorzata G Norton22019
Vijaya L Simhadri22019
Decarlos A Gomez22019
Omotunde O Osunsanmi22019
Unnee Ranjan12024
Travis S Bradley12024
Alan L Truong12023
Prajakta A Varadkar12023
Ze Peng12023
Pankaj H Amin12023
Scott T Ballard12023
Lu Deng12018
Joan Johnson12018
Bradley J Dworak12018
Irina Gaberman12018

Active Locations

Year-wise Inspection Count