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Sara M. Onyango

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FDA investigator. Took part in 89 inspections of 85 companies, 2016–2026.

Inspections (89)
DateCompanyClassificationProject areaInspection
September 10, 2026EUROFINS INPAC MEDIZINTECHNIK GMBHNot classified#1339350
September 3, 2026ILO Electronic GmbHVAICompliance: Devices#1334940
August 27, 2026Johnson & Johnson Vision Care Ireland UCNot classified#1336238
August 17, 2026Davol, Inc.VAIProject Evaluation: Devices#1333202
July 24, 2026Miach OrthopaedicsNot classifiedCompliance: Devices#1328256
April 1, 2026Arthrosurface, Inc.NAIPostmarket Assurance: Medical Devices#1311064
March 13, 2026Antron Engineering & Machine Co., Inc.NAICompliance: Devices#1307884
February 26, 2026SUMMA THERAPEUTICS, LLCNot classifiedCompliance: Medical Devices#1306234
January 15, 2026Expanse Medical Inc.NAIPostmarket Assurance: Medical Devices#1298960
January 12, 2026ZIIP INCNot classifiedCompliance: Medical Devices#1298958
December 22, 2025Ashland Specialty Ingredients, G.P.NAIPostmarket Assurance: Medical Devices#1297376
December 4, 2025Unetixs Vascular, Inc.OAICompliance: Medical Devices#1294258
October 28, 2025Criticare Technologies, Inc.OAICompliance: Medical Devices#1289170
August 8, 2025Fresenius Kabi USA, LLCOAICompliance: Devices#1278050
May 15, 2025Goodman Co., Ltd. Goodman Research CenterNAIBioresearch Monitoring#1274186
May 8, 2025Omnimate Enterprise Co., Ltd.Not classifiedCompliance: Medical Devices#1271152
May 1, 2025INSUNG MEDICAL CO LTDOAICompliance: Devices#1272999
April 23, 2025Miach OrthopaedicsOAICompliance: Medical Devices#1267715
March 11, 2025Primo Medical Group, IncNot classified#1263625
March 4, 2025Zimmer Biomet CMF and Thoracic LLCVAICompliance: Medical Devices#1262841
See all 89 inspections in the dashboard
Documents (52)
  • 483 · 3-D Matrix, Inc. · November 17, 2021
  • 483 · Magellan Diagnostics, Inc. · October 21, 2019
  • 483 · Criticare Technologies, Inc. · October 28, 2025
  • 483 · Whele LLC DBA Perch · June 6, 2022
  • 483 · Mannkind Corporation · October 3, 2024
  • 483 · Millstone Medical Outsourcing, LLC · December 18, 2024
  • 483 · Fresenius Kabi USA, LLC · August 8, 2025
  • 483 · Boston Scientific Corporation · November 26, 2024
  • 483 · Miach Orthopaedics · April 23, 2025
  • 483 · Suture Concepts · December 20, 2021
  • 483 · ConMed Corporation · September 22, 2020
  • 483 · SDI Diagnostics, Inc. · September 30, 2021
  • 483 · Exogenesis Corporation · April 12, 2022
  • 483 · Tech Group Europe Limited · April 27, 2023
  • 483 · Precision Optics Corporation, Inc. · March 31, 2023
  • 483 · SOPRO · July 21, 2022
  • 483 · Minta Medical Limited · July 28, 2022
  • 483 · Tecomet Inc. · January 9, 2020
  • 483 · Criticare Technologies, Inc. · May 10, 2024
  • 483 · Stryker Ireland, Ltd., Instruments Division · July 25, 2024
  • 483 · Magellan Diagnostics, Inc. · June 22, 2021
  • 483 · Analogic Corporation · August 25, 2022
  • 483 · J-PAC LLC · November 9, 2023
  • 483 · E. Benson Hood Laboratories, Inc. · February 20, 2024
  • 483 · Saphena Medical, Inc. · March 4, 2025
  • 483 · Century Pharmaceuticals, Inc. · October 25, 2022
  • 483 · Access Vascular, Inc. · October 6, 2022
  • 483 · Illuminoss Medical Inc. · February 1, 2024
  • 483 · Fresenius Kabi USA, LLC · September 7, 2023
  • 483 · Lymol Medical Corporation · February 12, 2020
  • 483 · NextPhase Medical Devices LLC · January 10, 2022
  • 483 · Liberty Engineering Inc · December 18, 2019
  • 483 · NeuroSync, Inc. · February 5, 2025
  • 483 · Whele LLC DBA Perch · July 18, 2023
  • 483 · 3-D Matrix, Inc. · October 18, 2023
  • 483 · Corindus Inc · July 27, 2021
  • 483 · Mobius Bionics, LLC · November 16, 2022
  • 483 · Waldemar Link GmbH & Co. KG (Mfg Site) · May 11, 2023
  • 483 · Zoe Medical Incorporated · September 20, 2019
  • 483 · LV Liberty Vision · April 26, 2022
  • 483 · Zyno Medical LLC · February 15, 2022
  • 483 · Future Diagnostics Solutions B.V. · January 19, 2023
  • 483 · InfuTronix LLC · February 15, 2022
  • 483 · Medmix US Inc. · December 6, 2022
  • 483 · Fresenius Kabi USA, LLC · March 18, 2022
  • 483 · Expanse Medical Inc. · January 15, 2026
  • 483 · ZIIP INC · January 12, 2026
  • 483 · ONC Solutions Incorporated · September 10, 2019
  • 483 · Maternova, Inc. · June 12, 2024
  • 483 · Ashland Specialty Ingredients, G.P. · December 22, 2025
  • 483 · SUMMA THERAPEUTICS, LLC · February 26, 2026
  • 483 · Arthrosurface, Inc. · April 1, 2026
Frequently inspected with (10)
Amanda N. Schaupp

investigator

4 shared
Maida Henesian

investigator

4 shared
James A. Lane

Investigator

3 shared
Andrew Betz
2 shared
Nabil Nakhoul
2 shared
Thomas Siebertz
2 shared
Clifton L. Randell

Microbiologist

1 shared
James P. Finn

investigator

1 shared
Quynh Strandberg

Regulatory Review Officer

1 shared
Stephen C. Smith

Investigator

1 shared
Person Information

Name

Sara M. Onyango

Role

ISSUING OFFICER

ID: 643c6ad3-9747-4bc2-9e8e-72f97b11e659

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