FDA Investigator Michael D Kawalek
Michael D Kawalek has inspections in 1 countries as of 06 Oct 2023. Michael D Kawalek has collaborated with a combined 1692 experts on various inspections, contributing to compliance and improvement across diverse sectors.
Investigator Details
Number of Inspected Sites:
11
Last Inspection Date:
06 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America
Co-Investigator(s):
Alexandra B Pitkin,
Aliza Chalapong Asawesna,
Amanda L Fyles,
Amir Alavi,
Ana Djurdjevic,
Anderson,
Andrews,
Bowman,
Bruce W Benware,
Bush,
Capri R Woolridge,
Carla J Lundi,
Carr Sharpe,
Carrie A Hughes,
CDR Rochelle B Young, RPh, MSA,
Charles L Larson,
Claudia Mperez Kasmarski,
Cynthia Jim, CSO,
Daniel R Solis,
David G Eng,
David G Whitman,
David J Leray,
Davis,
Deborah A Greco,
Dejon N Harris,
Dena L Jacobs,
Desiree C Iya,
Donna Ltartaglino Besone,
Durell L Giles,
Edna J Hidalgo,
Elaine S Chow,
Elizabeth P Mayer,
Gene D Arcy,
Geoffrey M Leist,
Greg K Keshishyan,
Harperd,
Henry E Carrillo,
James A Barreto,
James R Fleckenstein,
Jazmine M Welcher,
Jeff M Uriarte,
Jeffrey M Watson,
Jennifer M Gogley,
Jeremy H Nguyen,
Jocelyn E Massey,
John C Ho,
Jorge L Bertran,
Joseph Tibay,
Juanita Banuelos,
Judy C Nepsa,
Ka L Wong,
Karen L Bauer,
Katherine E Jacobitz,
Kelley,
Kelvin Cheung,
Kelvin X Sanders,
Kevin Lee,
Kevin T Gerrity,
Kimberly M Lichter,
Lance M De Souza, MBA,
Leonard H Lavi,
Lilly O Barton,
LT Richard A Lyght,
Lucila B Nwatu,
Marcus F Yambot,
Mariza M Jafary,
Maxyne T Lam,
Mei Chen Mu,
Michael D Garcia,
Michael S Araneta,
Michael S Call,
Nianna C Burns,
Norman Wong,
Omotunde O Osunsanmi,
Patricia F Alberico,
Paula A Trost,
Phal K Chhun,
Randy L Elsberry,
Rocio Guzman Velazquez,
Samina S Khan,
Sandra M Tallent,
Scott K Zika,
Selene T Torres,
Sonia R Peterson,
Sonya L Karsik,
State Agency,
Stephanie A Slater, MS,
Stephen D Brown,
Sundy Ven,
Tamala P Magee,
Tanya E Malais,
Terry A Hook, DPh,
Thao T Kwan,
Thomas C Mclean, CFS,
Trudy R Papson,
Uduak M Inokon,
Vickie L Anderson,
Victoria L Morgan,
Walden H Lee,
Yvette Mlacour Davis,
Yvonne T Lacour,
Zachary L Miller
Michael D Kawalek's Documents
Publish Date | Document Type | Title |
---|---|---|
September, 2009 | EIR | Advanced Sterilization Products - EIR, 2009-09-28 |
November, 2019 | EIR | Prolacta Bioscience Inc - EIR, 2019-11-22 |
September, 2013 | FDA 483 | Allergan Sales, LLC - Form 483, 2013-09-06 |
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.
![FDA Investigator Profile Icon](https://redica.com/document-store/images/InspectorProfile.png)
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