FDA Investigator Rachael L Cook

Rachael L Cook has conducted inspections on 41 sites in 2 countries as of 18 Mar 2019. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
41
Last Inspection Date:
18 Mar 2019
Investigator Role:
FDA Investigator
Redica ID:
100004087
Countries of Inspections:
United States of America, India
FDA Investigators that have inspected at least one site in common with Rachael L Cook:
Aaron P Wozniak, Abdollah Koolivand, Adam R Cooke, Alexis S Roberts, Amanda L Evanco, Ana L Kewes, Anastasia M Shields, Anthony S Puckett, Arlyss M Jones, Beth F Fritsch, Bonita S Chester, Brandon C Heitmeier, Brandy D Brown, Carol F Robinson, CDR Thomas R Berry, PPh, Chauncey A Stephens, Christopher C Wilcox, Christopher S Keating, Claudette D Brooks, Clifton L Randell, Constance Y Fears, Davia K Arnold, Demario L Walls, Derek C Price, Desiree D Clark, Devaughn Edwards, Diane P Goyette, Dorothy P Kramer, Dr. Robert C Horan, MD, Edward Deberry, Eileen J Bannerman, Ernest H Blackwood, Frank Wackes, Gabriel R Mclemore, Gary E Coleman, Jr, REHS, George G Calafactor, Geraldine D Sanders, Gideon N Esuzor, Hai Lient Phung, Ibad U Khan, Ivis L Negron, Jacqueline D Mitchell, Jamie L Port, Jamirya S Weatherly, Janaysia N Trail, Janet B Gray, Jared P Stevens, Jason F Chancey, Jason K Morgan, Jawaid Hamid, Jeffrey D Sheppard, Jessica L Pressley, Johnetta F Walters, Jonathan G Swoboda, Jose M Cayuela, Joseph F Owens, Juliana Falla, June P Page, Justin A Boyd, Kara D Dobbin, Katelynn J Rollins, Katherine Szestypalow, Kemejumaka N Opara, Kenny R Robinson, Kip J Hanks, Lareese K Thomas, Larry K Austin, Larry K Hampton, Laurie Nelson, Leah M Andrews, Leslie W Gilbert, Libia M Lugo, Lillie D Witcher, LT Tamara J Henderson, Luis A Dasta, Luis Mburgos Medero, Marcella D Crook, Marcia Gelber, Margaret M Annes, Marie F Mathews, Marie F Morin, Mary Jeanet Mcgarry, Matthew B Casale, Megan T Ziegler, Melanie M Walker, Michele Howard, N'jere English, Nancy E Fontaine, Narong Chamkasem, PhD, Navista C Bolton, Nelson A Rodriguez, Nicole A Lloyd, Nicole E Knowlton, Nije A Thomas, Noreen Muñiz, Penny H Mccarver, Postelle Birch Smith, R Edwadebey Deberry, Reba A Gates, Robert C Coleman, Robert L Lewis, Jr, Robert P Neligan, Robert Q Green, Rodney L Tinzie, Rory C Burton, Russell R Zablan, Sandra I Gaul, Santos E Camara, Saundrea A Munroe, Sayeeda Hdabe, Seneca D Toms, Sharna D Pratt, Shirley Brown, Shirley S Brown, Simone E Hollis, Sondra L Phillips, Song Y Lavalais, Sonya M Edmonds, Sookwang Lee, Steven A Brettler, Steven Fong, MS, PhD, Steven J Rush, Susan O Oladeji, Tamika D Cathey, Tara L Stockton, Theresa L Stewart, Tomika L Bivens, Tracy R Ball, Vanessa E Coulter, Veronica Fuentes, MS, Vicky C Stoakes, Victoria L Palmer, Vincent Thomas, Viviana Matta, William A Warnick, Yiyue Zhang (nmi), PhD, Yvins Dezan, Zhao Wang, PhD

Rachael L Cook's Documents

Publish Date Document Type Title
February, 2019 EIR Alcami Carolinas Corporation - EIR, 2019-02-21
January, 2018 FDA 483 PTI Royston, LLC - Form 483, 2018-01-11
July, 2017 FDA 483 Triangle Compounding Pharmacy Inc - Form 483, 2017-07-13
January, 2019 FDA 483 Mikart, LLC - Form 483, 2019-01-18
May, 2018 FDA 483 Glenmark Pharmaceuticals Inc., USA - Form 483, 2018-05-18
March, 2018 FDA 483 Newton Laboratories, Inc. - Form 483, 2018-03-30
June, 2016 FDA 483 Partners In Care, Inc. - Form 483, 2016-06-10
November, 2017 FDA 483 Farmville Discount Drug, Inc. DBA Best Value Drug - Form 483, 2017-11-17
January, 2016 FDA 483 Concord, Inc. dba Carlton's Dunwoody Pharmacy - Form 483, 2016-01-13
December, 2017 FDA 483 SC Johnson Professional USA, Inc. - Form 483, 2017-12-07
August, 2018 FDA 483 J B Chemicals and Pharmaceuticals Limited - Form 483, 2018-08-24
October, 2015 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2015-10-15
June, 2017 FDA 483 Laser Pharmaceuticals LLC - Form 483, 2017-06-01
April, 2017 EIR Nephron Sterile Compounding Center, LLC - EIR, 2017-04-21
July, 2018 FDA 483 King Bio Inc - Form 483, 2018-07-20
October, 2018 FDA 483 SC Johnson Professional USA, Inc. - Form 483, 2018-10-30
June, 2017 FDA 483 Response Laser Pharmaceuticals LLC - Form 483R, 2017-06-19
October, 2015 FDA 483 Pocono Coated Products - Form 483, 2015-10-30
April, 2017 FDA 483 Nephron Sterile Compounding Center, LLC - Form 483, 2017-04-21
July, 2018 FDA 483 Response King Bio Inc - Form 483R, 2019-02-13
October, 2015 FDA 483 Response Pocono Coated Products - Form 483R, 2015-11-17
January, 2018 EIR PTI Royston, LLC - EIR, 2018-01-11

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.

FDA Investigator Profile Icon

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