FDA Investigator Melanie G Warzala

Melanie G Warzala has inspections in 5 countries as of 13 Oct 2023. Melanie G Warzala has collaborated with a combinined 2504 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
128
Last Inspection Date:
13 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, France, Germany, Canada, Switzerland
Co-Investigator(s):
Aaron J Fox, Adaliz Santaliz Cruz, Adrienne D Thompkins, Althea A Williams, Andrea Dcharles Julien, Ashley A Mutawakkil, Ashley A Segura, Bill Tacket, Jr, Bora Veliu, Brian Ravitch, Brittny C Cargo, Carol S Davis, Carolyn E Barney, CDR Ileana Barreto Pettit, Christie A Soto, Christine M Humphrey, Christine M Parmentier, Christopher B May, Christos G Tsingelis, Clara E Santiago, Clausnitzer, Courtney A Gilbert, Darcy L Webber, Daryl A Dewoskin, Daveta L Baitley, David J Leray, David P King, Dawn M Braswell, Dianiris C Ayala, Dillard H Woody, Jr, Ebony D Sanon, Edward D Mcdonald, Edwards, Emma R Schaefer, Ernest A Clausnitzer, Gene R Gunn, Gerardo Z Vazquez, Giovanna Serpa, Gisselle I Sensebe, Glenn S Quintanilla, Gregson A Joseph, Harperd, Harshal J Desai, Howard A Webley, Hunt, Jacqueline S Warner, James D Planchon, James W Whitney, Jana L Caylor, Jason P Aun, Jennifer A Robinson, Jennifer Lalama, Jennifer S Ness, Jesse A Vazquez, Jessica L Pressley, Joan A Loreng, Joanne E King, Jolanna A Norton, Jontae D Sanders, Jose Alopez Rubet, Joseph T Goertz Jr, Joshua J Silvestri, Karen Emasley Joseph, Karen G Hirshfield, Karen M Cruz Arenas, Karen M Montgomery (KMM), Karen M Rodriguez, Karl D Hezel, Katelyn Astaub Zamperini, Kevin T Gerrity, Kim M Downing, Ladislav Kermet, Laiza V Garcia, Laura B Kennedy, Laura L Staples, LCDR Michael H Tollon, Lenora M Amason, Leo J Lagrotte, Leonard H Lavi, Leroy Terrelonge, Leslie A Cartmill, Leslie A Jackanicz, Liliane Brown, Linda K Matheny, Linda K Weir, Lisa A Warner, Lissette Paiz, Lizaida E Rodriguez, LT Daveta L Bailey, Lura D Baquero, Marc Balzarini, Maria Rubi, Marian E Ramirez, Mary A Millner, Matthew B Thomaston, Megan K Otero, Melanie W Pishnery, Melinda B Lewis, Mercedes B Mota, Michael D Gifford, Michelle J Glembin, Miguel A Martinez, Mizanne E Lewis, Monica Cburgos Garcia, Nicolas Riveratorres, Nicole E Knowlton, Nicole K Buck, Nikki S Bryant, Ormond, Pablo Alcantara, Paul A Licata, Paul L Figarole, Jr, Phillip M Pontikos, Reynolds, Richard K Vogel, Robert D Tollefsen, Robert W Calais, Rodney W Lenger, Ronald T Weber, Salvatore N Randazzo, Samantha J Pinizzotto, D V M, Sarah E Mcmullen, Saundrea A Munroe, Shari H Shambaugh, Sheirly J Reyes, Stanley B Eugene, BS, BME, State Agency, Stephanie D Crockett, Stephen D Eich, Steven A Brettler, Suzanne M Healy, Tamara M Casselman, Terry C Kimball, Thomas J Hudson, Traci M Armand, Tracy L Reed, Ulysses D Singleton, Vesa Vuniqi, Virginia L Meeks, Woody, Yehualashet A Gessesse

Melanie G Warzala's Documents

Publish Date Document Type Title
August, 2011 FDA 483 Advanced Orthogonal Equipment, Inc. dba Spinalight, Inc. - Form 483, 2011-08-18
May, 2012 FDA 483 Dynamic Pharmaceuticals, Inc. - Form 483, 2012-05-03
September, 2010 FDA 483 Gulf Fiberoptics, Inc. - Form 483, 2010-09-17
June, 2013 FDA 483 Biolife, LLC - Form 483, 2013-06-28
March, 2015 FDA 483 Ascom (US) Inc. - Form 483, 2015-03-27
June, 2013 FDA 483 Novalis Medical, LLC - Form 483, 2013-06-12
August, 2015 EIR Synergy Health North America - EIR, 2015-08-26
March, 2012 FDA 483 Pace Tech, Inc. - Form 483, 2012-03-19
January, 2013 FDA 483 The Lifestyle GP Company, LLC - Form 483, 2013-01-29
May, 2011 FDA 483 Gulf Fiberoptics, Inc. - Form 483, 2011-05-03
March, 2011 FDA 483 Apheresis Technologies, Inc. - Form 483, 2011-03-03
August, 2013 FDA 483 Parcus Medical, LLC - Form 483, 2013-08-16
October, 2013 FDA 483 The Lifestyle GP Company, LLC - Form 483, 2013-10-31
July, 2011 FDA 483 Pace Tech, Inc. - Form 483, 2011-07-13
August, 2012 FDA 483 HQ, Inc. - Form 483, 2012-08-03
January, 2010 FDA 483 Gulf Fiberoptics, Inc. - Form 483, 2010-01-12
February, 2012 FDA 483 Cardiocommand Inc. - Form 483, 2012-02-17
June, 2015 FDA 483 TRACOE Medical GmbH - Form 483, 2015-06-18
September, 2015 FDA 483 American Contract Systems, Inc. - Form 483, 2015-09-04
December, 2013 FDA 483 SmartScience Laboratories, Inc. - Form 483, 2013-12-06
February, 2015 EIR Stat Medical Devices, Inc. - EIR, 2015-02-20
February, 2013 FDA 483 Stellar Medical LLC. - Form 483, 2013-02-14
February, 2012 FDA 483 Scottcare Corporation - Form 483, 2012-02-08
January, 2015 FDA 483 Soft Computer Consultants, Inc. - Form 483, 2015-01-15
August, 2011 FDA 483 Smith & Nephew, Inc. - Form 483, 2011-08-31
April, 2012 FDA 483 Halkey Roberts Corp - Form 483, 2012-04-11
June, 2011 FDA 483 Orthopedic Designs North America, Inc. - Form 483, 2011-06-08
January, 2012 FDA 483 Bovie Medical Corporation - Form 483, 2012-01-18
May, 2013 FDA 483 Gulf Fiberoptics, Inc. - Form 483, 2013-05-06
September, 2011 FDA 483 Biopsy Sciences, LLC - Form 483, 2011-09-15
February, 2015 FDA 483 Response Stat Medical Devices, Inc. - Form 483R, 2015-03-12
December, 2009 FDA 483 Baxter Healthcare Corporation - Form 483, 2009-12-16

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.

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