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Roy Baby

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FDA investigator. Took part in 14 inspections of 14 companies, 2023–2026.

Inspections (14)
DateCompanyClassificationProject areaInspection
March 26, 2026Sterigenics Shanghai ETO Ltd.Not classified#1311286
March 19, 2026Unicon Optical Co., LTDNot classified#1311008
March 12, 2026United Orthopedic Corp.Not classified#1311010
March 10, 2026GERRESHEIMER PEACHTREE CITY LPNot classified#1308758
January 16, 2026LivaNova USA, Inc.Not classified#1302110
July 2, 2025Goodier Cosmetics LLCNAICompliance: Devices#1257837
June 18, 2025Nelson Enviromental Technologies, Inc.NAIPostmarket Assurance: Medical Devices#1273193
May 29, 2025Morgan Newton Comp.NAIPostmarket Assurance: Medical Devices#1271082
January 27, 2025Acuity Surgical Devices, LLCNAIPostmarket Assurance: Medical Devices#1259220
January 14, 2025Delasco IncVAICompliance: Medical Devices#1258336
December 16, 2024Swiss American CDMO, LLCNAIPostmarket Assurance: Medical Devices#1251710
September 26, 2023Steri-Tek, LLCVAICompliance: Devices#1220467
March 17, 2023Orthofix U.S. LLCVAICompliance: Devices#1200226
January 9, 2023Genesis Biosystems, IncNAIPostmarket Assurance: Devices#1195256
Documents (28)
  • 483 · Rapid Biomedical GmbH · July 2, 2018
  • 483 · Pfm Medical Cpp SA · July 9, 2018
  • 483 · Zhangzhou Aoxi Plastics Co., Ltd. · December 4, 2017
  • 483 · Zhongshan A & J Medical Equipment Co., Ltd. (JBS) · July 18, 2016
  • EIR · Nurse Assist, LLC · March 9, 2020
  • EIR · ErgoMed, Inc. · August 23, 2019
  • 483 · AutoMedx, LLC · January 24, 2020
  • 483 · Meko · February 21, 2019
  • 483 · Rapid Biomedical GmbH · July 5, 2018
  • 483 · Swiss American CDMO, LLC · December 16, 2024
  • 483 · Delasco Inc · January 14, 2025
  • EIR · Strukmyer LLC · May 25, 2018
  • 483 · Nelson Enviromental Technologies, Inc. · June 18, 2025
  • 483 · Morgan Newton Comp. · May 29, 2025
  • 483 · Acuity Surgical Devices, LLC · January 27, 2025
  • 483 · Orthofix U.S. LLC · March 17, 2023
  • 483 · Austco Marketing & Service LTD. · September 23, 2022
  • 483 · GRAMERCY EXTREMITY ORTHOPEDICS · October 6, 2022
  • 483 · Cogent Technology, Ltd. · February 14, 2019
  • 483 · Zhangzhou Aoxi Plastics Co., Ltd. · December 6, 2017
  • 483 · ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. (JBS) · July 20, 2016
  • 483 · Genesis Biosystems, Inc · January 9, 2023
  • 483 · MPM Medical LLC · December 12, 2019
  • 483 · Pfm Medical Cpp SA · July 11, 2018
  • 483 · Domino Pads, LLC · August 21, 2019
  • 483 · Wello, Inc. · October 10, 2019
  • 483 · Ideal Implant Incorporated · February 3, 2020
  • 483 · Libra Industries, LLC · August 2, 2019
Frequently inspected with (6)
Elizabeth A. Krolczyk
4 shared
Katherine M. Thames
3 shared
Terri E. Gibson
2 shared
Katlin N. Stubbs
1 shared
Miaja Umaedi
1 shared
Yuliana Hernandez-Magana
1 shared
Person Information

Name

Roy Baby

Title

issuing_officer

Role

COMPANY REP

ID: 69a18ef5-167c-41eb-a57e-3d138a0820c2

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