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  1. OII Inspectorates

Office of Biologics Inspectorate (OBI)

The Office of Biologics Inspectorate (OBI), within the Office of Inspections and Investigations (OII), is responsible for protecting the public health by conducting domestic and international inspections and investigations to assure the safety, efficacy, and quality of a wide range of biological and related products, including licensed and approved drugs, and licensed and cleared devices.  OBI inspects firms that manufacture products regulated by the Center for Biologics Evaluation and Research (CBER) including blood and blood products, human cells, tissues, and cellular and tissue-based products (HCT/Ps), source plasma, fractionated and recombinant blood derivative products, antivenins, immunization toxoids, vaccines, allergenic products, hematopoietic progenitor cell (HPC), cord blood, gene therapies, cellular therapies, xenotransplantation products, live biotherapeutic products, in vitro diagnostics including HIV and donor screening test kits, and other medical devices regulated by CBER.  Other products inspected by OBI include animal biotechnology products, such as intentional genomic alterations (IGA) of animals and animal cells, tissues, and cell- and tissue-based products (ACTPs) regulated by the Center for Veterinary Medicine (CVM).  

OBI inspections focus on: 

  • Regulated entities manufacturing biological products, both domestic and foreign 
  • Compliance with CGMP requirements 
  • Compliance with CGTP requirements 
  • Collaboration with international regulatory partners

OBI’s Mission

Our mission is to protect public health by assuring the safety, efficacy, and quality of biological products. 

What we do

  • Domestic and foreign inspections and investigations of regulated entities manufacturing biological products, ACTPs, and IGAs 
  • Training and outreach to industry and academia 
  • Collaboration with international regulatory partners 
  • Collaboration with CBER and CVM on regulated products and new initiatives

Who we are

Ginette Michaud, MD, Office Director
Office Telephone: 240-402-8331 
Email: Ginette.Michaud@fda.hhs.gov 

Susan M. Turcovski, Deputy Office Director
Office Telephone: 407-475-4702 
Email: Susan.Turcovski@fda.hhs.gov 

Contact OBI 

Inspectorate Division

Boundaries

Division Director

Inspectorate I

AL, AR, FL, GA, KY, LA, MS, OH, OK, PR, TN, TX

Karlton Watson, Division Director
Division of Biologics Inspectorate I
Office phone: 214-253-5254 
Email: OIIOBIBiologicsInspectionalCorrespondence@fda.hhs.gov 

Inspectorate II

CT, DC, DE, MA, MD, ME, MI, MN, NC, ND, NH, NJ, NY, PA, RI, SD, VA, VT, WI, WV 

LCDR Jogy George, Acting Division Director
Division of Biologics Inspectorate II
Office Phone: 914-682-2826 X 24 
Email: OIIOBIBiologicsInspectionalCorrespondence@fda.hhs.gov 

Inspectorate III

AK, AZ, CA, CO, Guam, HI, IA, ID, IL, IN, KS, MO, MT, NE, NM, NV, OR, Saipan, UT, WA, WY  

Aneel Sandhu, Acting Division Director
Division of Biologics Inspectorate III
Office phone: 510-337-6875 
Email: OIIOBIBiologicsInspectionalCorrespondence@fda.hhs.gov 

Biotechnology Inspectorate

Domestic and International 

CDR Jeremy Wally, PhD, Acting Division Director
Division of Biotechnology Inspectorate
Office phone: 240-402-7458 
Email: OIIOBIBiologicsInspectionalCorrespondence@fda.hhs.gov 

 

 


 



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