FDA Investigator Gisselle I Sensebe

Gisselle I Sensebe has conducted inspections on 35 sites in 2 countries as of 08 Jul 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Gisselle I Sensebe's Documents

Publish Date Document Type Title
August, 2023 FDA 483 Forsure Medical Products, LLC - Form 483, 2023-08-17
February, 2022 FDA 483 Empowered Diagnostics LLC - Form 483, 2022-02-25
August, 2022 FDA 483 Biodominium Diagnostics - Form 483, 2022-08-12
March, 2024 FDA 483 Zizion Group, LLC - Form 483, 2024-03-12
September, 2022 FDA 483 Gutizmultiservices Inc - Form 483, 2022-09-29
March, 2022 FDA 483 Michael D. Williams, D.D.S., P.A. - Form 483, 2022-03-31
June, 2023 FDA 483 Boca Dental Regenerative LLC - Form 483, 2023-06-05
March, 2022 FDA 483 MobileHelp, LLC - Form 483, 2022-03-11
November, 2023 FDA 483 Scientific Supplies & Technology, Inc. - Form 483, 2023-11-09
May, 2022 FDA 483 Legend Aerospace, Inc. - Form 483, 2022-05-27
November, 2022 FDA 483 FloSpine, LLC - Form 483, 2022-11-18
December, 2022 FDA 483 Agora Edge - Form 483, 2022-12-14
September, 2023 FDA 483 ARCADLAB LLC - Form 483, 2023-09-01
May, 2023 FDA 483 Suncoast Dental, Inc. dba Tatum Surgical - Form 483, 2023-05-04
June, 2024 FDA 483 Empyrean Medical Systems Inc - Form 483, 2024-06-05
February, 2024 FDA 483 Advance-Esthetic LLC - Form 483, 2024-02-07
September, 2024 FDA 483 Sarasota Medical Products, Inc. - Form 483, 2024-09-12
November, 2024 FDA 483 JB Medical Development LLC - Form 483, 2024-11-19
January, 2025 FDA 483 Peterson Dental Laboratory Inc. - Form 483, 2025-01-08
April, 2025 FDA 483 Healthcare Logistics Systems, LLC, D/B/A Healthcare Logiix Systems - Form 483, 2025-04-02
February, 2025 FDA 483 Merits Health Products, Inc. - Form 483, 2025-02-27

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