FDA Investigator Karen M Jirele
Karen M Jirele has conducted inspections on 8 sites in 1 countries as of 17 Sep 2001. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
8
Last Inspection Date:
17 Sep 2001
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
United States of America
FDA Investigators that have inspected at least one site in common with Karen M Jirele:
Alfred P Pistorio,
Alison A Nicoli,
Amy L Mcintyre,
Carolyn A Warren,
Christina A Castineyra,
Courtney R Tiegs,
Dacia E Quick,
Darlene L Krieger,
David B Wieneke,
Demetria L Downs,
Demetria L Lueneburg,
Douglas R Nelson,
Edward A Fabiano,
Elias H Wachter,
Elizabeth P Mayer,
Garrett W Steiner,
Heather Akleimola Hulbert,
Ivan E Reyes,
Jake T Lane,
Jamie R Thompson,
Jane E Nelson,
Jean M Trimbo,
Jennifer R Mathern,
Jon C Polzine,
Justin A Boyd,
Karen M Gasperic,
Karen M Labounty,
Karla J Youngberg,
Katherine A Clarke Girolamo,
Kathy Ac Girolamo,
Kellie L Thommes, RN,
Kellie L Westerbuhr,
Kibily D Dembele,
Kristy E Zuroski,
Larae M Koopman,
Lauren E Sanger,
Mada A Tautges,
Maria E Treadwell,
Melissa D Kalik,
Mohammed H Adam,
Paola E Lathrop,
Peter T Erlandson,
Rebecca L Mullikin,
Robert H Claflin,
Sana A Elassar,
Sandra Sejdinovic,
Seth A Abbott,
Theresa C Klaman,
Victoria L Palmer,
Zachary P Wachlarowicz
Karen M Jirele's Documents
Publish Date | Document Type | Title |
---|---|---|
August, 2000 | EIR | University of Minnesota Medical Center, Fairview - EIR, 2000-08-31 |
June, 2000 | EIR | Mead Johnson and Co., LLC - EIR, 2000-06-21 |
February, 2000 | EIR | Gerber Products Company dba Nestle Nutrition-Eau Claire - EIR, 2000-03-03 |
January, 2001 | EIR | Gerber Products Company dba Nestle Nutrition-Eau Claire - EIR, 2001-01-30 |
November, 2000 | EIR | Hearthside Food Solutions, LLC - EIR, 2000-11-08 |
March, 2000 | FDA 483 | Nestle Healthcare Nutrition Inc. - Form 483, 2000-03-24 |
July, 2001 | FDA 483 | Mead Johnson and Co., LLC - Form 483, 2001-07-12 |
March, 2000 | EIR | Nestle Healthcare Nutrition Inc. - EIR, 2000-03-24 |
July, 2001 | EIR | Mead Johnson and Co., LLC - EIR, 2001-07-12 |
September, 2001 | EIR | Nestle Healthcare Nutrition Inc. - EIR, 2001-09-21 |
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](/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