Paul Z Balcer

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Lakewood CO 80225

Organizations: DHHS FDA CDER OMPT CDER OC OMQ

Total Inspections: 54

Total 483s Issued: 28

Total Warning Letters Issued: 1

Inspection Details

Longest Inspection: 32 days

Shortest Inspection: 1 days

Average Length of Inspection: 3.8 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2015-04-29Grupo Taifeld's S.A. de C.V.MexicoMexico3007209614
2015-04-28Dysal S.A. de C.V.HuixquilucanMexico2000022031
2015-04-22Laboratorios Griffith de Mexico, S. A. de C. V.AtitalaquiaMexico3004258405
2015-04-21General Mills- Gigante Verde S de RL de CVIrapuatoMexico3006531114
2015-04-16Dulceria GallardoSan Juan de los LagosMexico3011360206
2015-04-14SAZON DE MI CORAZONSan Lorenzo Cacaotepec EtlaMexico3004665358
2015-02-25CBR International Corp.BoulderUnited States3011083184
2015-02-11Amgen, Inc.BoulderUnited States3003072024
2015-02-11Amgen, IncorporatedLongmontUnited States3002892484
2015-02-11Amgen Manufacturing LtdJuncosUnited States1000110364

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Co-Inspectors

NameInspectionsLast Inspection
Zachery L Miller52015
William A Warnick52015
Zachary L Stamm32015
Michael A Charles32015
Jamie L Dion32014
Isabel Y Espinosa32012
Ashleigh P Wodushek22015
Kathryn M Mogen22014
Kristen E Szenderski22014
Elisa J Beard22012
Marie B Buen-Bigornia22012
William J Leonard12015
Teena H Aiken12014
Brittany R Laymon12014
Laura B Kennedy12014
Ashleigh P Barkans12013
Jennifer R Mathern12013
Caroline H Le12012
Isaiah Isakson12012
Edith M Gonzalez12012
Matthew A Johnson12012
Patrick W Mcafee12011
Jennifer A Baker12011

Active Locations

Year-wise Inspection Count