Michael R Klapal

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Silver Spring MD 20705

Organizations: DHHS FDA CDER OMPT CDER OPQ OPF DIA IABIII

Total Inspections: 115

Total 483s Issued: 61

Total Warning Letters Issued: 1

Inspection Details

Longest Inspection: 40 days

Shortest Inspection: 1 days

Average Length of Inspection: 4.2 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2019-04-16KVK Tech, Inc.NewtownUnited States3005117563
2018-05-17Advanced Accelerator Applications USA, Inc.MillburnUnited States3012484129
2018-02-09Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)RavensburgGermany3005987757
2017-06-27KVK Tech, Inc.NewtownUnited States3005117563
2016-09-12Ferring ProductionParsippanyUnited States3011163401
2015-11-03Petnet Solutions, Inc.HackensackUnited States3007044510
2015-09-30ImprimisRx NJLedgewoodUnited States3003348498
2015-08-26Genzyme CorporationRidgefieldUnited States2246315
2015-07-10ImClone Systems, LLCBranchburgUnited States3002889358
2015-06-24SOFIE Co. dba SOFIESomersetUnited States3005705951

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Co-Inspectors

NameInspectionsLast Inspection
Valerie C Reed52011
Liatte Krueger42015
Stephen J Mottola42013
Douglas C Kovacs42013
Lauren L Vajo32013
Michael Serrano32011
Daniel J Grabicki32009
Nicholas A Violand22019
Helen Verdel22016
Christina N Maurino22015
Steven M Weinman22015
Thomas J Arista22015
Zakaria I Ganiyu22015
Nikki S Ramirez22014
Charles Chacko22014
Nicole A Lloyd22014
Jonee J Mearns22012
Dawn L Wydner22011
Karen E Dorazio22010
Patric C Klotzbuecher12019
Yvesna C Blaise12019
Thuy T Nguyen12018
Adetutu M Gidado12018
Junho Pak12017
Bijoy Panicker12017
Juanita P Versace12016
Jogy George12015
Unnee Ranjan12015
Saleem A Akhtar12015
Tonia F Bernard12015
Niketa Patel12015
Tamil Arasu12015
Dinesh Kumar12014
Toyin B Oladimeji12014
Jose M Cayuela12014
Charles Cote12013
Alberto A Viciedo12013
Doreen P Gubbay12013
Gianine E Tompkins12013
Eric J Cunningham12012
Larry K Austin12011
Miguel G Manzano12011
Annette Melendez12011
Denise M Visco12010
Kazi Rafiquzzaman12009
Erin D Mccaffery12009
Manhar R Patel12009
Byungja E Marciante12008

Active Locations

Year-wise Inspection Count