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Katarzyna Plona

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FDA investigator. Took part in 75 inspections of 67 companies, 2023–2026.

Inspections (75)
DateCompanyClassificationProject areaInspection
October 1, 2026Aero-Med LLCNAICompliance: Devices#1339660
September 10, 2026Clearstream Technologies LtdNot classified#1336196
September 4, 2026Bayer OYNot classified#1335430
August 19, 2026Blueroot Health, Inc.NAIPostmarket Assurance: Devices#1331668
August 12, 2026CRYON-X LLCVAICompliance: Devices#1330984
August 4, 2026Baron Analytical Laboratories LLCNAICompliance: Devices#1329770
July 24, 2026AdDent, Inc.NAIPostmarket Assurance: Devices#1327692
June 17, 2026Memry CorporationNAIPostmarket Assurance: Devices#1323672
June 9, 2026JMBH HOLDINGS LLCNAICompliance: Devices#1321646
May 26, 2026Biowave CorporationVAIPostmarket Assurance: Devices#1319378
May 13, 2026Biorez, IncNAICompliance: Devices#1317704
April 21, 2026Spine Wave, Inc.NAIPostmarket Assurance: Devices#1314334
April 8, 2026Medcraft LLCNAIPostmarket Assurance: Devices#1311480
March 12, 2026Jabil Switzerland Manufacturing GmbHNAICompliance: Devices#1310648
March 5, 2026Sterigenics SASNot classified#1309544
February 26, 2026Siemens Healthcare Diagnostics Products Ltd.NAIPostmarket Assurance: Devices#1309226
February 10, 2026Putnam Medical CorporationNAIPostmarket Assurance: Devices#1303100
January 13, 2026ROM Technologies, Inc.NAICompliance: Devices#1298938
December 18, 2025Falck Medical IncorporatedNAICompliance: Devices#1296642
December 4, 2025Contract Medical ManufacturingNot classified#1295490
See all 75 inspections in the dashboard
Documents (31)
  • 483 · Cetro America Inc. · February 1, 2024
  • 483 · West-Conn Tool & Die Inc. · November 10, 2022
  • 483 · Silex Medical, LLC · April 23, 2025
  • 483 · Hobbs Medical, Inc. · August 27, 2021
  • 483 · Ikonisys Inc. · October 12, 2022
  • 483 · Calmare Therapeutics, Inc. · May 22, 2024
  • 483 · UniSoft Medical Corporation · January 19, 2023
  • 483 · Prototype & Plastic Mold Company, Inc. · January 10, 2025
  • 483 · U-Smell-It Llc · May 22, 2025
  • 483 · TRUMEDX LLC · June 26, 2025
  • 483 · Q30 Sports Science, Llc · October 12, 2023
  • 483 · AdDent, Inc. · December 8, 2022
  • 483 · MIRA, Inc. · June 12, 2024
  • 483 · SoClean, Inc · February 6, 2023
  • 483 · MIRA, Inc. · March 7, 2023
  • 483 · Kat Implants, LLC · September 16, 2022
  • 483 · Biowave Corporation · June 21, 2023
  • 483 · Conair LLC · October 22, 2025
  • 483 · Insite One · October 31, 2025
  • 483 · Interscope, Inc. · May 5, 2023
  • 483 · Myriad Fiber Imaging Technologies, Inc. · July 29, 2022
  • 483 · Rapid Oxygen Inc. · April 26, 2024
  • 483 · Titan Manufacturing, Inc. · August 9, 2023
  • 483 · Simply Clean Air & Water Inc. · April 29, 2022
  • 483 · ROM Technologies, Inc. · April 4, 2023
  • 483 · Kelyniam Global, Inc. · August 23, 2024
  • 483 · Proxtalker.Com, Llc · November 18, 2025
  • 483 · Oxford Performance Materials, Inc. · August 2, 2024
  • 483 · AdDent, Inc. · July 24, 2026
  • 483 · CRYON-X LLC · August 12, 2026
  • 483 · Biowave Corporation · May 26, 2026
Frequently inspected with (3)
Carolina D. Vasquez
1 shared
Jeffrey J. Thibodeau

Power Trader/Data Scientist

1 shared
Stephen C. Smith

Investigator

1 shared
Person Information

Name

Katarzyna Plona

ID: ea20d6c6-5d2d-41a0-a755-0647fb9f3250

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