Michele Gottshall - FDA Investigator Report

Designation: Regulatory Officer

Duty Station: Wilkes Barre PA 18702

Organizations: DHHS FDA ORA ORA OMPTO OPQO DPQOI PQIBI

Overview Statistics

50
Total Inspections
21
Total 483s Issued
2
Warning Letters Issued

Inspection Details

Longest Inspection: 39 days
Shortest Inspection: 1 days
Average Length: 5.0 days

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Michele Gottshall's Recent Inspections

DateCompanyCityCountryFEI Number483
2025-04-10Penn State Health Holy Spirit - Blood Donor CenterCamp HillUnited States3004750112
2025-03-27American National Red Cross (The) Carolinas RegionCharlotteUnited States1073007
2025-03-12Penn State Health Hampden Medical CenterEnolaUnited States3020688593
2025-02-13Biomat USA, Inc.AllentownUnited States3014576101
2025-01-22Novus Surgical Consultants LLCMechanicsburgUnited States3025552951
2024-10-24Central Pennsylvania Blood BankHarrisburgUnited States1000307044
2024-10-10American Red Cross Blood ServicesScrantonUnited States1000221279
2024-09-10Shady Grove Fertility Center of Pennsylvania, PLLCMechanicsburgUnited States3010646515
2024-09-09Novus Surgical Solutions LLCEast PetersburgUnited States3012790952
2024-08-21Kimera Labs IncMiramarUnited States3011069063

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Michele Gottshall - Co-Inspectors

NameInspectionsLast Inspection
Kish Bolden32024
Truong X Nguyen32023
Victoria V Bot22024
Amy A Johnson22024
Anastasia M Shields22022
David E Lowe12025
Marla A Cassidy12025
Matthew J Gretkierewicz12025
Emily A Walters12024
Mizanne E Lewis12024
Charles D Boison12024
Laurissa S Flowers12024
Brandy N Lepage12022
Maureen A Wentzel12022
Guerlain Ulysse12022
James M Mason12022
Karen A Briggs12021
Junho Pak12021
Melissa M Schafer12020
Nancy M Espinal12020
Alan D Centi12019
Crystal A Harlan12019
Brian S Keefer12019

Michele Gottshall's Active Locations

  • United States
  • Canada
  • India
  • Japan
  • Taiwan
  • Australia

Michele Gottshall's Year-wise Inspection Count

  • 2019:2 inspections
  • 2020:2 inspections
  • 2021:3 inspections
  • 2022:9 inspections
  • 2023:13 inspections
  • 2024:16 inspections
  • 2025:5 inspections
Last Updated: 2025-05-14 06:11:22