FDA Investigator Calvin K Cook
Calvin K Cook has conducted inspections on 194 sites in 8 countries as of 18 Jul 2011. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
194
Last Inspection Date:
18 Jul 2011
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America,
India,
Ireland,
Korea (Republic of),
France,
Australia,
Taiwan
FDA Investigators that have inspected at least one site in common with Calvin K Cook:
Adrian D Land,
Adrianna G Vargo,
Akbar J Zaidi,
Alexandra A Carrico,
Althea A Williams,
Amanda L Baskin,
Amina Bashir,
Amy S Graf,
Andrea D Swingle,
Andrew H Paeng,
Antonio M Hampton,
Ashleigh P Barkans,
Ava M Bowman,
Barbara D Bennett,
Bei Y He,
Benjamin J Smith,
Bernard P Heidt,
Bleta Vuniqi,
Brandi N Mcgrady,
Brenda L Reihing,
Brian J Mundo,
Brian M Campbell,
Brian M Marosan,
Brian P Hendrickson,
Brian P Putz,
Brian R Yaun,
Brittany M Lowe,
Bryan J Love,
Byron Ho, DVM,
CDR Kimberly Y Martin,
CDR Sean T Creighton,
Charles E Frelix,
Charles L Larson,
Charles M Spyr,
Chase S Baldwin,
Chelsea J Falkowski,
Chelsea J Snider,
Christi L Bellmore,
Christopher J Hurst,
Corrine M Carter,
Crystal M Young Lewis,
Cynthia A Harris, MD, RN,
Cynthia L Aycock,
Cynthia Li,
Daniel J Gorski,
Danny Tuntevski,
Dariusz Galezowski,
David A Paterson,
David J Gasparovich,
Dawn C Olenjack,
Debara R Reese,
Deborah A Nebenzahl,
Dennis R Downer,
Dipesh K Shah,
Dolores Harper,
Donna K Speer,
Edwardstine J Reese,
Emest F Bizjak,
Emily J Orban,
Eric E Joneson,
Eric M Padgett,
Eric S Pittman,
Francis J Eng,
Frank Verni,
Gary Durbiel Goldner,
Gary L Zaharek,
George G Calafactor,
Hans T Meyers,
Ifueko Osemwota,
Jacob A Clark,
James A Lane,
James D Hildreth,
James E Szelc,
James M Odonnell,
James N Rench,
Jeff A Gard,
Jeffrey A Sommers,
Jennifer R Johnson,
Jocelyn M Muggli,
John A Hall,
John A Sciacchitano,
John D Jaworski,
John E Emmert,
John N Woodall,
Joie A Navarrete,
Joseph R Strelnik,
Julia A Avery,
Juliane C Lessard,
K Gonzlez,
Karen A Coleman,
Karl D Hezel,
Kathryn A Guardiola,
Kathryn G Brown,
Kelley L Clark,
Kennita Riddick,
Kinh Q Mac,
Kristina Mezin,
Kristina Nastovski,
Kunapuli T Madhusudhan,
Kwong P Lee,
Larry K Austin,
Laureen M Geniusz,
Lauren E Burke,
Lauren E Sexton,
LCDR Anastasia M Piliafas Brown,
LCDR Matthew R Mcnew, MPH, REHS/RS,
Leigh Anne Myers,
Leonard H Lavi,
Lewis K Antwi,
Linda S Jozefiak,
Lisa M Thursam,
Lori J Silverstein,
Lorna F Jones,
LTJG Aaron B Otis,
Maribeth G Grattan,
Maribeth G Niesen,
Marlon K Turner,
Martin R Vowell,
Meisha R Sampson,
Meisha Waters,
Melanie W Pishnery,
Melina Lrodriguez Upton,
Misty D Harvey,
Monica J Wilkins,
Msdap Gonzlezk,
Muna Algharibeh,
Myra K Casey,
Nancy A Bellamy,
Natalie A Mickelsen, DVM,
Neal D Singletary, PhD,
Neali H Lucas,
Nelson,
Norman Wong,
Patricia H Dlugosz,
Patrick B Cummings,
Rafeeq A Habeeb,
Ralph Jerndal,
Rasha Bamieh,
Rebecca E Dombrowski,
Richard T Riggie,
Robert G Ruff,
Robert M Barbosa,
Robert P Neligan,
Rodney B Ross,
Rohn R Robertson,
Rosanna M Goodrich,
Rupa Pradhan,
Ryan J Benedict,
Sara M Onyango,
Sargum C Sood,
Scott A Nabe,
Shannon A Gregory,
Shaquenta Y Perkins,
Sherri N Rohlf, MD,
Stanley B Eugene, BS, BME,
Suyang Qin,
Talmane J Fisher,
Tarsha T Mcclendon,
Thai T Duong,
Theodore N Sietsema,
Thomas A Peter,
Thursaml,
Tony T Yang,
Tracey L Siebesma,
Travis S Bradley,
Vera M Anderson,
Vesa Vuniqi,
Vickie L Adkins,
William D Tingley,
William G Nelson,
William R Brubaker,
Xiaojun Yan,
Yehualashet A Gessesse
Calvin K Cook's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| January, 2005 | EIR | DePuy Orthopaedics, Inc. - EIR, 2005-01-19 |
| April, 2011 | FDA 483 | Symbios Medical Products, LLC - Form 483, 2011-04-22 |
| May, 2010 | EIR | Nestle-usa, Inc. - EIR, 2010-05-21 |
| October, 2010 | FDA 483 | Caire, Inc. - Form 483, 2010-10-08 |
| January, 2008 | FDA 483 | DePuy Orthopaedics, Inc. - Form 483, 2008-01-22 |
| March, 2007 | FDA 483 | Roche Diagnostics Operations, Inc. - Form 483, 2007-03-09 |
| May, 2009 | FDA 483 | Hologic, Inc. - Form 483, 2009-05-20 |
| September, 2009 | FDA 483 | King Systems Corp. dba Ambu, Inc. - Form 483, 2009-09-04 |
| January, 2008 | EIR | DePuy Orthopaedics, Inc. - EIR, 2008-01-22 |
| April, 2005 | FDA 483 | CrestLab, Inc. - Form 483, 2005-04-28 |
| February, 2009 | FDA 483 | Sunrise Medical US, LLC - Form 483, 2009-02-09 |
| September, 2009 | FDA 483 | Century Pharmaceuticals, Inc. - Form 483, 2009-09-10 |
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