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Edward D. McDonald

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FDA investigator. Took part in 72 inspections of 65 companies, 2016–2026.

Inspections (72)
DateCompanyClassificationProject areaInspection
September 16, 2026Gentell, IncNot classified#1342948
September 3, 2026Hill LaboratoriesNAIPostmarket Assurance: Devices#1334112
April 23, 2026Savaria Concord Lifts, Inc.Not classified#1320858
April 17, 2026Motion Concepts LPNot classified#1320118
March 3, 2026Mytamed IncVAICompliance: Devices#1307894
February 26, 2026Bear-Ent, LlcNot classifiedCompliance: Medical Devices#1304536
October 16, 2025Globus Medical, Inc.VAICompliance: Medical Devices#1253116
June 5, 2025Sleep Specialists, LLCNAICompliance: Devices#1274065
May 22, 2025Drummond Scientific CompanyNAICompliance: Devices#1274066
May 20, 2025Uramix IncVAICompliance: Medical Devices#1270251
May 6, 2025Zober Industries, Inc.Not classified#1274612
March 26, 2025MW Life Sciences - HatfieldNAIPostmarket Assurance: Devices#1267615
March 13, 2025FRUH PACKAGING INC.NAICompliance: Devices#1266483
November 25, 2024B & G Mfg. CoNot classified#1257065
September 26, 2024Unilene SacNot classified#1252190
September 20, 2024B.Braun of Dominican Republic Inc.NAIPostmarket Assurance: Devices#1248210
September 12, 2024Arriol International Corp.NAIPostmarket Assurance: Devices#1251375
May 14, 2024Siemens Healthcare Diagnostics, Inc.Not classified#1278130
March 7, 2024Globus Medical, Inc.OAIPostmarket Assurance: Devices#1230609
November 15, 2023Stoner IncorporatedNAIPostmarket Assurance: Devices#1222860
See all 72 inspections in the dashboard
Documents (20)
  • 483 · Reading Hospital · December 16, 2015
  • 483 · Forge Medical Inc. · July 18, 2018
  • 483 · Globus Medical, Inc. · October 16, 2025
  • 483 · Uramix Inc · May 20, 2025
  • 483 · Gentell, Inc · December 12, 2019
  • 483 · Sonic Systems Inc · September 26, 2019
  • 483 · Stoner Incorporated · November 15, 2023
  • 483 · DSM Biomedical, Inc. · February 12, 2018
  • 483 · Gentell · December 16, 2019
  • 483 · B&W TEK, Inc. · December 8, 2021
  • 483 · Hearing Lab Technology, LLC · April 20, 2023
  • 483 · Spring Health Products Inc · March 22, 2022
  • 483 · Globus Medical, Inc. · March 7, 2024
  • 483 · Spring Health Products Inc · December 18, 2018
  • 483 · Superior Surgical, Llc · March 10, 2022
  • 483 · Hill Laboratories · July 27, 2022
  • 483 · Siemens Medical Solutions USA, Inc · October 26, 2022
  • 483 · Gentell, Inc · August 25, 2015
  • 483 · Environmental Tectonics Corp · August 1, 2019
  • 483 · Bear-Ent, Llc · February 26, 2026
Frequently inspected with (1)
Brian S. Keefer

Investigator at US Food and Drug Administration

4 shared
Person Information

Name

Edward D. McDonald

Title

Investigations

Role

Regulatory Personnel

ID: 69224613-2b96-426a-99dd-e1cfe5ff1713

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