FDA Investigator Paul Z Balcer
Paul Z Balcer has conducted inspections on 54 sites in 3 countries as of 01 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
54
Last Inspection Date:
01 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America,
Puerto Rico,
Mexico
FDA Investigators that have inspected at least one site in common with Paul Z Balcer:
Adaliz Santaliz Cruz,
Alan A Rivera,
Alan P Kurtzberg,
Alicia A Armijo,
Andrea George, PhD,
Andrea J Schmidt,
Andrew J Gonzales,
Andrew M Kolenc,
Ann Marie Montemurro,
Antonetta M Colacchio,
Arlene M Badillo,
Ashleigh P Barkans,
Ashleigh P Wodushek,
Ashley M Caputo,
Ashley N Queen, PhD,
Azotearc,
Bodenw,
Brent W Higgs,
Brittany R Laymon,
Bryce A Hammer,
Calvin B Koerner,
Carla Lankford, MD, PhD,
Carla R Hinz,
Carmen Ramirez,
Caroline H Le,
Carrie E Jolly,
Christine I Shaw,
Christine L Williams,
Christopher Downey, PhD,
Colleen Thomas, PhD,
Connie Lucero,
Daniel J Lahar,
Daniel Pst Laurent,
David A Gonzalez,
David Frucht, MD,
Debra L Curtis,
Dennis Cantellops Paite,
Donald C Obenhuber, PhD,
Dov H Pluznik, PhD,
Dr. Zhihao Qiu (Peter), PhD,
Duc Minh H Nguyen,
Edith M Gonzalez,
Eliezar Ramos,
Elisa J Beard,
Elvin R Smith,
Eric C Behrens,
Eric S Myskowski,
Erika V Butler,
Felix J Marrero,
Frank L Cordova,
Gary C Pecic, Jr,
Gina M Scholze,
Ginger M Sykes,
Grace E Mcnally,
Hanna L Potter,
Harry A Wilson,
Holly L Miller,
Isabel Y Espinosa,
Isaiah D Isakson,
Ivis L Negron,
Jacqueline Mdiaz Albertini,
James R Montero,
Jamie L Dion,
Jamie L Port,
Janet Pulver,
Jennifer A Baker,
Jennifer Lalama,
Jennifer R Mathern,
Jerri Baker,
Jianming Li,
Jin M Kim,
Joel D Hustedt,
John A Gonzalez,
Jorge L Lajara,
Jose A Lopez,
Jose Acruz Gonzalez,
José E Meléndez,
Jose R Lopez,
Jose Velez,
Joshua C Schafer,
Judy M Amaya,
Kalavati Suvarna, PhD,
Kathryn M Mogen,
Keith C Littrell,
Kimberley A Hoefen,
Kristen E Szenderski,
Larry Gehring,
Laura B Kennedy,
Lavender M Huskey,
Libia M Lugo,
Linda M Cheny,
Lisa Shin,
Lisa T Michel,
Lori A Carr,
LT Rafael Gonzalez,
Manuel A Moreno,
Maria Gutierrez Lugo, PhD,
Marian E Ramirez,
Marie B Buen Bigornia,
Marlene G Swider,
Marlo Ianm Alintanahin,
Marquez D Berrianvalle,
Marsha L Mccauley,
Mary F Bodick,
Matthew A Johnson,
Matthew M Vernon,
Matthew R Dionne,
Maxwell Van Tassell, PhD,
Meaghan M Rabideau,
Michael A Charles,
Michael E Maselli,
Michael J Kuchta,
Michael L Zimmerman,
Michael R Goga,
Michael Shanks, MS,
Michelle D Motsinger,
Michelle Yclark Stuart,
Mihaly S Ligmond,
Milva E Melendez Perales,
Myriam M Sosa,
Nancy G Schmidt,
Nathan R Moon,
Nayan J Patel,
Nicholas Obiri, PhD,
Nikolay Spiridonov,
Noreen Muñiz,
Nydia E Colon,
Oluwaseyi Ojinni,
Omotunde O Osunsanmi,
Patricia A Brown,
Patricia A Cortez,
Patricia A Maestas,
Patricia F Hughes, PhD,
Patrick W Mcafee,
Paul J Teitell,
Paul Lihong Yeh, PhD,
Paula A Trost,
Ramesh Potla, PhD,
Ramon A Hernandez,
Rebecca E Dombrowski,
Rebecca Parrilla,
Rebecca Rodriguez,
Rebecca S Secrist,
Richard W Thornton,
Ricki A Chase,
Riley C Myers, PhD,
Robert D Tollefsen,
Robert Darius,
Rose Ashley,
Samantha E Rafferty,
Shererk,
Solomon G Williams,
Sri H Pfuntner,
Steve P Yost,
Steven C Madzo,
Steven Fong, MS, PhD,
Steven O Gauthier,
Susan F Laska, MS,
Teena H Aiken,
Thai T Duong,
Theressa B Smith,
Thomas J Arista,
Thomas V Anderson,
Timothy Wadkin, PhD,
Traci B Bickell,
Trevor R Beach,
Verlinda A Narcisse,
Vilmary Negron Rodriguez,
Wendy G Tan, PhD,
William A Warnick,
William D Boden,
William J Leonard,
Zachary L Miller,
Zachary L Stamm,
Zhong Li, PhD
Paul Z Balcer's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| February, 2015 | FDA 483 Response | Amgen, Inc. - Form 483R, 2015-02-27 |
| February, 2015 | FDA 483 | Amgen, Incorporated - Form 483, 2015-02-11 |
| February, 2013 | FDA 483 | Kasel Associates Industries, Inc. - Form 483, 2013-02-14 |
| February, 2014 | FDA 483 | Smiley National Inc - Form 483, 2014-02-28 |
| February, 2015 | EIR | Amgen, Inc. - EIR, 2015-02-11 |
| April, 2015 | FDA 483 | Dysal S.A. de C.V. - Form 483, 2015-04-28 |
| February, 2015 | FDA 483 | Amgen, Inc. - Form 483, 2015-02-11 |
| January, 2015 | FDA 483 | Zynex Medical, Inc. - Form 483, 2015-01-29 |
| February, 2013 | EIR | Kasel Associates Industries, Inc. - EIR, 2013-02-14 |
| February, 2015 | EIR | Amgen, Incorporated - EIR, 2015-02-11 |
Experience Redica Systems’ NEW investigator profiles and dashboards
Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:
- Total inspections conducted
- 483 rate
- OAI rate
- Warning Letter rate
- Inspections by Industry, Scope, and Inspection Reason
- And much more
Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.
Talk to sales to access our investigator profiles
Loading...
Investigator Profiles Are Just the Tip of the Iceberg
Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:
Inspection Intelligence
- Pre-Approval Inspection (PAI) trends
- The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
- Latest 483s: see what the trends are across all FDA Investigators
- CFR Heatmap: Citations aggregated by Subpart by Year
Vendor Intelligence
- Full inspection histories for your vendors down to the specific site level
- All of the functionality mentioned above but isolated to just your vendors
Regulatory Intelligence
- Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
- All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more