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Debara R. Reese

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FDA investigator. Took part in 36 inspections of 29 companies, 2016–2024.

Inspections (36)
DateCompanyClassificationProject areaInspection
September 19, 2024Sterigenics Radiation Technologies IN, IncVAICompliance: Medical Devices#1250801
September 21, 2023Arcamed LLCVAI#1218335
June 16, 2023Eli Lilly & CompanyNot classified#1209522
May 16, 2023King Systems Corp. dba Ambu, Inc.OAICompliance: Devices#1206518
January 30, 2023Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.NAICompliance: Devices#1197996
September 18, 2019Advanced Engineering, Inc.VAICompliance: Devices#1102693
August 23, 2019Lantz Medical, Inc.VAICompliance: Devices#1101050
July 25, 2019Roche Diabetes Care, Inc.VAIPostmarket Assurance: Devices#1097946
June 28, 2019The Lebanon Corporation, Inc.VAICompliance: Devices#1095739
May 20, 2019Parker Medical Systems Division MerillvilleVAIProject Evaluation: Devices#1090202
April 17, 20193MNAIPostmarket Assurance: Devices#1087946
March 29, 2019SonarMed IncVAICompliance: Devices#1084308
March 5, 2019Eli Lilly & CompanyNAICompliance: Devices#1082843
February 15, 2019Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.OAIPostmarket Assurance: Devices#1080894
September 7, 2018Boston Scientific CorpNot classified#1066569
August 23, 2018Cook Medical LLCVAICompliance: Devices#1063415
June 14, 2018Cook IncorporatedNAIPostmarket Assurance: Devices#1057227
April 26, 2018Innovative Surgical Designs, Inc.NAIPostmarket Assurance: Devices#1049811
March 28, 2018Med-Mizer, Inc.NAIPostmarket Assurance: Devices#1048337
March 6, 2018Arcamed LLCVAIProject Evaluation: Devices#1043484
See all 36 inspections in the dashboard
Documents (16)
  • EIR · Tegra Medical Costa Rica Sa · May 18, 2017
  • 483 · King Systems Corp. dba Ambu, Inc. · April 15, 2021
  • 483 · Dot America, Inc. · June 14, 2021
  • 483 · Cook Incorporated · February 7, 2020
  • 483 · Sterigenics Radiation Technologies IN, Inc · September 19, 2024
  • 483 · Advanced Engineering, Inc. · September 18, 2019
  • 483 · Analytical Control Systems, Inc · December 19, 2019
  • 483 · LH Medical Corporation · March 19, 2020
  • 483 · Arcamed LLC · September 21, 2023
  • 483 · Cook Medical LLC · August 23, 2018
  • 483 · Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. · September 7, 2021
  • 483 · The Lebanon Corporation, Inc. · June 28, 2019
  • 483 · Roche Diabetes Care, Inc. · July 25, 2019
  • 483 · Eli Lilly & Company · June 16, 2023
  • 483 · Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. · February 15, 2019
  • 483 · Lantz Medical, Inc. · August 23, 2019
Frequently inspected with (8)
Melina L. Rodriguez-Upton
2 shared
Robert M. Barbosa
2 shared
Brittany M. Lowe
1 shared
Corrine M. Carter

investigator

1 shared
Frank Wackes

Investigator

1 shared
Ian A. Pilcher

Investigator

1 shared
Sargum C. Morgan
1 shared
Wayne E. Seifert

Senior Regulatory Specialist

1 shared
Person Information

Name

Debara R. Reese

Role

ISSUING OFFICER

ID: 277a8fbb-ba4d-4402-be08-16d7977685db

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