FDA Investigator Amy S Graf

Amy S Graf has inspections in 6 countries as of 30 Aug 2023. Amy S Graf has collaborated with a combinined 2630 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
59
Last Inspection Date:
30 Aug 2023
Investigator Role:
FDA Investigator
Redica ID:
100003815
Country:
United States of America, Denmark, Ireland, Taiwan, Canada
Co-Investigator(s):
Adam J Wilson, Alanna Lmussawwir Bias, Alexandra A Carrico, Allison M Scheck, Amber M Capello Jones, Amy M Cramer, Andrea D Swingle, Anthony F Lorenzo, Anthony R Petriella, Art O Czabaniuk, Azza Talaat, Barbara A Rusin, Bei Y He, Benjamin J Dastoli, Benjamin J Smith, Bernard P Heidt, Bleta Vuniqi, Brian J Mundo, Brian M Campbell, Brian P Putz, Byungja E Marciante, Calvin K Cook, Catherine V Quinlan, CDR Sean T Creighton, Charles M Spyr, Christian D Lynch (CDL), Christina L Bigham, Cynthia L Aycock, Cynthia Li, Daniel J Brown, David J Gasparovich, David J Gsparovich, Deanna L Lampley, Debara R Reese, Deborah M Trout, Dennis R Hock, Dipesh K Shah, Donald W Myrick, Emilie E Kahn, Emily J Orban, Emmanuel A Dimaano, Jr, Eric E Joneson, Eric S Pittman, Erma Zaimova, Felix J Marrero, Gary Durbiel Goldner, George G Calafactor, German Rivera, Gregory A Cronce, Harperd, Hartman, Hokenson, Jacob G Lutz, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Lane, James E Frye, James E Szelc, James R Evans, James W Leonette, Jeffrey D Meng, Jennifer A Kemp, John N Woodall, Joohi Castelvetere, Joseph A Piechocki, Joseph R Strelnik, Joseph T Madak, Karen L Kosar, Katherine E Jacobitz, Kim M Downing, Kimberley A Ricketts, Kimberly Lewandowski Walker, Kinh Q Mac, Kristina Mezin, Larry K Austin, Laureen F Kononen, Laureen M Geniusz, Lauren E Burke, Lauren E Sexton, Lauren M Lilly, PhD, Laurie B Frazier, LCDR Anastasia Mpiliafas Brown, Leonard H Lavi, Leslie A Paul, Lindsey Brown, PhD, Lisa A Warner, Lisa P Oakes, Lori S Lawless, Marc S Neubauer, Margaret N Persich, Maribeth G Grattan, Maribeth G Niesen, Marissa S Steinhagen, Martha Sullivan Myrick, Matthew H Pitts, Matthew J Gretkierewicz, Melina Lrodriguez Upton, Miah I Schneider, Michael K Larson, Michael Shanks, MS, Michael W Burd, Michele L Forster, PhD, Michelle L Jones, Mihaly S Ligmond, Myra K Casey, Neali H Lucas, Omotunde O Osunsanmi, Paige E Shelborne, Patrick B Cummings, Patsy J Domingo, Phillip M Pontikos, Prabhu P Raju, Rafeeq A Habeeb, Rasha Bamieh, Rebecca E Dombrowski, Richard T Riggie, Robert G Ruff, Robert G Taylor, Rosanna M Goodrich, Rose M Ashley, Roy Baby, Ryan J Benedict, Salwa K Poole, Sanket N Patel, Sarah E Rhoades, Sarah M Meng, Sarah M Napier, Sargum C Manley, Sargum C Sood, Scott C Gonzalez, Shannon A Gregory, Sherri J Jackson, Shirshendu K Deb, PhD, Sidney B Priesmeyer, State Agency, Susan M Jackson, Suyang Qin, Talmane J Fisher, Teresa K Kastner, Thomas A Peter, Tina M Pawlowski, Tina S Roecklein, Tracey L Siebesma, Tracey L Taylor, Twana R Chandler, Vesa Vuniqi, William D Tingley, William G Nelson, William R Brubaker

Amy S Graf's Documents

Publish Date Document Type Title
July, 2016 EIR Sterling Diagnostics, Inc. - EIR, 2016-07-28
June, 2014 EIR Biomet, Inc. - EIR, 2014-06-30
April, 2019 FDA 483 Response Par Sterile Products LLC - Form 483R, 2019-05-02
April, 2015 FDA 483 Panoramic Rental Corp. - Form 483, 2015-04-24
July, 2016 FDA 483 Sterling Diagnostics, Inc. - Form 483, 2016-07-28
December, 2014 FDA 483 Freeman Enterprise LLC - Form 483, 2014-12-16
April, 2019 EIR Par Sterile Products LLC - EIR, 2019-04-15
April, 2019 FDA 483 Par Sterile Products LLC - Form 483, 2019-04-15
July, 2015 FDA 483 FRONTIER MEDICAL DEVICES INC. - Form 483, 2015-07-24
April, 2015 EIR Rockwell Medical, Inc - EIR, 2015-04-03
April, 2015 FDA 483 Rockwell Medical, Inc - Form 483, 2015-04-03
March, 2016 EIR Amigo Mobility International, Inc - EIR, 2016-03-24
November, 2017 FDA 483 MedImage, Inc. - Form 483, 2017-11-02
November, 2016 FDA 483 Contour Fabricators Inc - Form 483, 2016-11-10
October, 2015 FDA 483 DePuy Orthopaedics, Inc. - Form 483, 2015-10-01
April, 2015 FDA 483 Response Rockwell Medical, Inc - Form 483R, 2015-04-28
June, 2014 FDA 483 Response Biomet, Inc. - Form 483R, 2014-07-21
February, 2017 EIR Signal Medical Corporation - EIR, 2017-02-03
January, 2017 FDA 483 Ascensia Diabetes Care U.S. Inc. - Form 483, 2017-01-10
May, 2016 FDA 483 BroadMaster Biotech Corp. - Form 483, 2016-05-05
September, 2016 FDA 483 Panoramic Rental Corp. - Form 483, 2016-09-07
March, 2017 FDA 483 MichClone Associates, Inc. - Form 483, 2017-03-09
February, 2017 FDA 483 Signal Medical Corporation - Form 483, 2017-02-03
April, 2018 FDA 483 Trillium Technology, Inc. - Form 483, 2018-04-30
October, 2014 FDA 483 Xoran Technologies, LLC - Form 483, 2014-10-06
October, 2016 FDA 483 Acumedia Manufacturers, Inc. - Form 483, 2016-10-07
January, 2016 FDA 483 Unique Instruments, Inc. - Form 483, 2016-01-22
June, 2014 FDA 483 Biomet, Inc. - Form 483, 2014-06-30
November, 2014 FDA 483 Ossur Americas, Inc. - Form 483, 2014-11-21
March, 2016 FDA 483 Amigo Mobility International, Inc - Form 483, 2016-03-24
May, 2018 FDA 483 Ultrasound Medical Devices, Inc. - Form 483, 2018-05-23
July, 2015 FDA 483 Response FRONTIER MEDICAL DEVICES INC. - Form 483R, 2015-08-10
April, 2015 FDA 483 Progressive Dynamics, Inc. - Form 483, 2015-04-07
May, 2014 FDA 483 Axiobionics, LLC - Form 483, 2014-05-15
March, 2016 FDA 483 Response Amigo Mobility International, Inc - Form 483R, 2016-03-25

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