FDA Investigator Karen A Wolnik
Karen A Wolnik has inspections in 1 countries as of 05 Nov 2021. Karen A Wolnik has collaborated with a combinined 1851 experts on various inspections, contributing to compliance and improvement across diverse sectors.
Investigator Details
Number of Inspected Sites:
5
Last Inspection Date:
05 Nov 2021
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America
Co-Investigator(s):
Adalberto Cajigas,
Alyson C Tanner,
Arie C Menachem,
Bichsa T Nguyen,
Bichsa T Tran,
Binh T Nguyen,
Brenda S Zimmer, PhD,
Carla J Lundi,
Carr Sharpe,
Carrie A Hughes,
Caryn M Everly,
Caryn M Mcnab,
Cassandra L Abellard,
Cynthia J Lee, MS,
Cynthia Jim, CSO,
Dejon N Harris,
Diane Cvan Leeuwen,
Dr. Chunchang Fang,
Erika V Butler,
Frank L Cordova,
Frederick Fricke,
Frederick L Fricke,
Fredrick L Fricke,
Ginger M Sykes,
Haroon Vohra (NMI),
Isabel Y Espinosa,
Ivis L Negron,
Ivis Lnegron Torres,
Jamie L Dion,
Joe X Phillips,
Joey V Quitania,
John A Gonzalez,
Jorge L Guadalupe,
Jose E Melendez, DDC,
Jose Velez,
Joseph X Philips,
Kari M Johansen,
Katherine E Jacobitz,
Katherine Szestypalow,
Kenneth V Miller,
Kent C Faul,
Kham Phommachanh,
Kim Lthomas Cruse,
Kimberley A Hoefen,
Lakecha N Lewis,
Libia M Lugo,
Liming Zhang,
Linda M Cheny,
Linda Thai,
Lourdes Andujar,
Margarita Santiago,
Marianela Aponte Cruz,
Marie Falcone,
Marie T Falcone,
Matthew R Dionne,
Michael A Charles,
Michael D Garcia,
Michael J Kuchta,
Michael Kuchta,
Michael R Goga,
Miguel A Martinez,
Miguel Hernandez Sanchez,
Nathan M Jornod,
Nayan J Patel,
Noreen Muniz,
Patricia A Brown,
Patricia A Cortez,
Patricia Brown,
Peter C Chow,
Rafael Nevarez Nieves,
Rakhi B Shah,
Ramon A Hernandez,
Rebecca H Lee,
Rebecca Parrilla,
Rebecca Rodriguez,
Robert Sharpnack,
Ryan J Borges,
Saied A Asbagh,
Sandra S Saniga,
Santiago Gallardo Johnson,
Sean P Desbrow,
Sonia M Monges,
Steven B Barber,
Steven E Porter, Jr,
Sue Lee Chan,
Tenzin Jangchup,
Terri L Dodds,
Thai T Duong,
Thanh M Andrews,
Thao T Kwan,
Theressa B Smith,
Thomas R Beilke,
Tony J Wu,
Tracey T Duong,
Truong Xuan Nguyen (Andy),
Uttaniti Limchumroon (Tom),
Valerie L Whipp,
Vashti E Bocker,
Virgilio F Pacio, CSO,
Walden H Lee,
Walden Lee,
William J Leonard,
Yasamin Ameri,
Yumi J Hiramine,
Zachary L Miller,
Zachary L Stamm
Karen A Wolnik's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| September, 2000 | EIR | Watson Laboratories, Inc. - EIR, 2000-09-14 |
| August, 2001 | EIR | Sandoz Incorporated - EIR, 2001-08-24 |
| February, 2002 | EIR | Bristol-Myers Squibb Manufacturing Company Unlimited Company - EIR, 2002-02-28 |
Experience Redica System's 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