Erik W Koester

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Stoneham MA 02180

Organizations: DHHS FDA ORA OGROP ORA OMPTO OPQO DPQOI PQIBI

Total Inspections: 133

Total 483s Issued: 102

Total Warning Letters Issued: 2

Inspection Details

Longest Inspection: 189 days

Shortest Inspection: 1 days

Average Length of Inspection: 15.1 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2025-03-20GC Hanford Manufacturing CompanySyracuseUnited States1310197
2025-02-19Azurity Pharmaceuticals, Inc.WilmingtonUnited States3003395329
2025-01-15PLZ CorpFall RiverUnited States1221967
2024-11-22PolyPeptide Laboratories Private LimitedAmbarnathIndia3009051788
2024-11-15Itrace Pharmaceutical Solutions Private LimitedThaneIndia3018238790
2024-11-11Siddharth Carbochem Products LimitedJalgaonIndia3013284388
2024-09-11Professional Disposables International, Inc.OrangeburgUnited States2411192
2024-06-24Safecor Health, LLCWoburnUnited States1218914
2024-05-24Lyophilization Services of New England, Inc.BedfordUnited States3008546445
2024-04-16Molecular MS Diagnostics, LLCWarwickUnited States3011589219

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Download 483s and EIRs for Erik W Koester

Co-Inspectors

NameInspectionsLast Inspection
Robert J Martin262022
John P Mistler222020
Sean R Marcsisin72024
Jonah S Ufferfilge62022
Daniel L Zheng52022
Dien N Nguyen52016
Jonathan G Matrisciano32024
Josh Renzo N Ramilo32023
Armen H Youssoufian22025
Kristina L Conroy22022
Rachael O Oyewole22022
Vivin George22022
Simone E Pitts22022
Christina K Theodorou22022
Bijoy Panicker22022
Holly M Zahner22019
Eric M Silberhorn22019
Katherine L Huebner22019
Margaret M Sands22019
Harlan J Howard22019
Stephen C Smith22018
Stacey S Degarmo22015
Ifechimere I Okafor12025
Christian F Gomez Lugo12025
Ogechi C Nna12025
Divek R Jumani12024
Jenny Sung12024
Karishma G Gopaul12024
Samuel J Arsenault12023
Lane V Christensen12023
Margaret M Doherty12022
Terry Bridgewater12022
Alice S Tsao12022
Lori M Newman12021
Samir C Gala12020
Chhaya S Shetty12019
Angela J Davis12018
Yaodong Huang12018
Xiaoping Guan12018
Richard A Abate12017
Victoria M Daddeo12017
Lashanda M Long12016
Michelle A Marsh12016
Mary-Jeanet Mcgarry12015
Alysia M Salonia12015
Slater K Bartlett12015
Jayaleka J Amarasinghe12014
Edmund F Mrak12014

Active Locations

Year-wise Inspection Count

Last Updated: 2025-05-14 06:11:22