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Richard K. Vogel

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FDA investigator. Took part in 73 inspections of 71 companies, 2016–2019.

Inspections (73)
DateCompanyClassificationProject areaInspection
September 11, 2019Apollo Renal Therapeutics, LLCNAIPostmarket Assurance: Devices#1103309
September 5, 2019Wayne Metal Products, Inc.NAICompliance: Devices#1101690
August 16, 2019American Contract Systems, Inc.OAICompliance: Devices#1100396
August 7, 2019American Industrial Plastics, LLCNAICompliance: Devices#1101128
July 31, 2019DyAnsys, IncVAIPostmarket Assurance: Devices#1098593
July 19, 2019Atlas Spine, Inc.NAIPostmarket Assurance: Devices#1097562
July 16, 2019DB Diagnostic Systems Inc.VAICompliance: Devices#1097561
June 28, 2019Awareness Technology, Inc.VAICompliance: Devices#1095264
June 26, 2019Ecotec Manufacturing, Inc.VAIPostmarket Assurance: Devices#1095263
June 17, 2019Iradimed CorporationVAICompliance: Devices#1093942
May 31, 2019Accessibility Services, Inc.VAICompliance: Devices#1091632
May 17, 2019Photonic Health, LLCVAIPostmarket Assurance: Devices#1090448
April 18, 2019Ward Photonics, LLCVAIPostmarket Assurance: Devices#1086770
April 5, 2019Xhale Assurance, Inc.Not classifiedCompliance: Devices#1085814
March 14, 2019Medequip Implant Supplies, LLCVAICompliance: Devices#1083207
March 13, 2019Excel Medical Electronics LLCVAICompliance: Devices#1083206
February 13, 2019FLEXMEDICAL SOLUTIONS LIMITEDVAIProject Evaluation: Devices#1079411
February 6, 2019MBM PRINT SCS LIMITEDNAICompliance: Devices#1082352
January 31, 2019Keter Canada, Inc.Not classifiedCompliance: Devices#1079410
December 6, 2018Intelligent Retinal Imaging Systems Inc.NAIPostmarket Assurance: Devices#1074319
See all 73 inspections in the dashboard
Documents (27)
  • 483 · Invacare Corporation · August 18, 2010
  • 483 RESPONSE · Invacare Corporation · September 8, 2010
  • EIR · Exactech, Inc. · January 31, 2020
  • 483 · Advanced Concept Innovations LLC · August 17, 2017
  • 483 · Nephron Pharmaceuticals Corp. · February 21, 2014
  • 483 · Exactech, Inc. · March 10, 2017
  • 483 · Heartware, Inc. · January 24, 2014
  • 483 · PN Medical, Inc. · October 17, 2019
  • 483 · Apollo Renal Therapeutics, LLC · September 11, 2019
  • 483 · Nuline Sensors LLC · January 29, 2016
  • 483 · FLEXMEDICAL SOLUTIONS LIMITED · February 13, 2019
  • 483 · Genicon, Inc. · January 17, 2020
  • 483 · Magnatone Hearing Aid Corp · December 10, 2019
  • 483 · Encore, Inc. · February 20, 2020
  • 483 · DB Diagnostic Systems Inc. · July 16, 2019
  • 483 · Acorn Stairlifts, Inc · July 16, 2021
  • 483 · Kalitec Direct, LLC · March 4, 2020
  • 483 · Ecotec Manufacturing, Inc. · June 26, 2019
  • 483 · Exactech, Inc. · January 31, 2020
  • 483 · Intelligent Retinal Imaging Systems Inc. · December 6, 2018
  • 483 · Photonic Health, LLC · May 17, 2019
  • 483 · Xhale Assurance, Inc. · April 5, 2019
  • EIR · Ecotec Manufacturing, Inc. · June 26, 2019
  • 483 · Excel Medical Electronics LLC · March 13, 2019
  • 483 · Atlas Spine, Inc. · July 19, 2019
  • 483 · International Sterilization Laboratory, LLC · October 10, 2019
  • 483 · American Contract Systems, Inc. · August 16, 2019
Frequently inspected with (2)
Gamal A. Norton
2 shared
David M. Wilkinson
1 shared
Person Information

Name

Richard K. Vogel

Title

Principal

Role

Regulatory Personnel

ID: 3ddd8bff-24fd-40ee-b0a7-fb5333a520f5

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