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Nakesh N. Gomanie

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FDA investigator. Took part in 11 inspections of 11 companies, 2024–2026.

Inspections (11)
DateCompanyClassificationProject areaInspection
March 10, 2026ClorDiSys Solutions LLCNot classified#1310656
January 16, 2026Trutek CorpNot classifiedCompliance: Medical Devices#1298746
December 18, 2025DiAgam Societe Anonyme (S.A.)Not classifiedCompliance: Medical Devices#1295808
December 11, 2025KCI POLYMEDICS BVNot classifiedCompliance: Medical Devices#1295806
December 4, 2025ADRIA SRLNot classifiedCompliance: Medical Devices#1293884
August 21, 2025Datascope Corp.Not classifiedCompliance: Medical Devices#1272550
June 5, 2025Portal 724 LLCVAICompliance: Medical Devices#1271790
May 7, 2025Trinity Medical Devices, Inc.NAIPostmarket Assurance: Medical Devices#1269741
April 4, 2025Onkos Surgical, Inc.Not classifiedCompliance: Medical Devices#1265813
January 8, 2025Mkj Brands, Llc.NAIPostmarket Assurance: Medical Devices#1258034
October 24, 2024James Alexander Corp.VAICompliance: Medical Devices#1230186
Documents (12)
  • 483 · American Spraytech LLC · April 11, 2024
  • 483 · Portal 724 LLC · June 5, 2025
  • 483 · Mkj Brands, Llc. · January 8, 2025
  • 483 · Trinity Medical Devices, Inc. · May 7, 2025
  • 483 · Datascope Corp. · August 21, 2025
  • 483 · BihlerMed, LLC · November 30, 2023
  • 483 · Next Medical Products Company, LLC · April 7, 2023
  • 483 · Life Recovery Systems HD, LLC · September 11, 2023
  • 483 · Comar Inc. · April 18, 2024
  • 483 · Onkos Surgical, Inc. · October 26, 2023
  • 483 · Onkos Surgical, Inc. · April 4, 2025
  • 483 · Phillips Precision, Inc. · July 17, 2024
Frequently inspected with (5)
Jaro P. Perera
2 shared
Naakesh N. Gomanie
2 shared
Colin E. Tack
1 shared
Esteban Beltran
1 shared
Jonathan Ho
1 shared
Person Information

Name

Nakesh N. Gomanie

Role

ISSUING OFFICER

ID: cfffa8e1-fdfb-4bc4-a845-44bcd593c9c7

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