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
David K. Glasgow, Acting Office Director
Office Telephone: 301-796-5403
Email: David.Glasgow@fda.hhs.gov
Aneel Sandhu, Acting Deputy Office Director
Office Telephone: 510-337-6875
Email: Aneel.Sandhu@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, SC, SD, VA, VT, WI, WV | CDR 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 | Karlton Watson, Acting Division Director Division of Biologics Inspectorate III Office phone: 214-253-5254 Email: OIIOBIBiologicsInspectionalCorrespondence@fda.hhs.gov |
| Biotechnology Inspectorate | Domestic and International | CDR Jogy George, Acting Division Director Division of Biotechnology Inspectorate Office phone: 914-682-2826 X 24 Email: OIIOBIBiologicsInspectionalCorrespondence@fda.hhs.gov |