FDA-TRACK ORA Regional Offices

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The FDA-TRACK ORA Regional Offices dashboard includes:

• Office of Regional Operations (ORO) - ORO coordinates and manages all FDA field operations, serving as the central point within the agency through which offices may obtain field support services.  ORO, and its five operating divisions, has specific responsibilities in the following areas: domestic and foreign inspections and investigations (including National Experts, dedicated foreign inspection cadres, and Team Biologics inspection operations); Office of Regulatory Affairs (ORA) emergency response coordination; import operations and policy; federal/state relations, contracts, partnerships and cooperative agreements; science and operational policy, coordination, and support services involving ORA field laboratory operations; coordination with laboratories in the Food Emergency Response Network; and operation of the Prior Notice Center since its inception in 2002. ORO provides expert guidance to the Associate Commissioner for Regulatory Affairs on inspection, investigation, import, state relations, and analytical operations.
• Five Regional Field Offices - ORA’s public health goal is to reduce illnesses and deaths from FDA-regulated products by maximizing compliance and minimizing risk associated with those products. The five Regional Field Offices support this goal by working to eliminate the risk of products and industry practices that do not meet FDA compliance standards:

1. Regional Field Office, Central Region, Philadelphia, PA
2. Regional Field Office, Northeast Region, Jamaica, NY
3. Regional Field Office, Pacific Region, Oakland, CA
4. Regional Field Office, Southeast Region, Atlanta, GA
5. Regional Field Office, Southwest Region, Dallas, TX

 

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