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  1. OII Inspectorates

Office of Human and Animal Drug Inspectorate (OHADI)

The Office of Human and Animal Drug Inspectorate (OHADI), a program within the Office of Inspections and Investigations (OII), provides advice and counsel to OII and FDA leaders regarding pharmaceutical products, field operations, and emergency response activities. OHADI collaborates with the agency’s Center for Drug Evaluation & Research (CDER) and the Center for Veterinary Medicine (CVM) on all FDA-regulated pharmaceutical and biopharmaceutical products.

OHADI coordinates, directs, and assists with pharmaceutical product investigative activities, including conducting investigations and inspections of pharmaceutical products, as well as providing technical assistance regarding pharmaceutical investigational operations. As part of FDA’s implementation of the Prescription Drug User Fee Act, Food and Drug Administration Safety and Innovation Act, and the Generic Drug User Fee Amendment, OII, CDER, and CVM partner to develop annual work plans and strategic priorities for inspections, compliance, analysis, and import operations.

OHADI's Mission 

Protect consumers / patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products. We will accomplish this by our inspections & investigations of facilities who manufacture drugs for human and animal use. Our inspections ensure the safety, efficacy and security of the human & animal drug supply.

Vision 

To be the global leader in ensuring the safety efficacy and security of human & animal drugs through innovative approaches, using risk-based inspections. Thus, public health is protected promoted and advanced.

OHADI boundary map
OHADI boundary map

Divisions: 

  • OHADI 1: Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont
  • OHADI 2: Delaware, District of Columbia, Kentucky, Maryland, Ohio, Pennsylvania, Virginia, West Virginia 
  • OHADI 3: Florida, Georgia, North Carolina, Puerto Rico, South Carolina, U.S. Virgin Islands 
  • OHADI 4: Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, South Dakota, Wisconsin
  • OHADI 5: Alabama, Arizona, Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, Tennessee, Texas, Utah, Wyoming
  • OHADI 6: Alaska, American Samoa, California, Guam, Hawaii, Idaho, Montana, Nevada, Northern Mariana Islands, Oregon, Washington

Senior Leadership 

Photo of Ivy Sweeney

Ivy Sweeney, Acting Director
Office Telephone: 404-669-4551
Email: ivy.sweeney@fda.hhs.gov 

View Bio

Rebecca Dowd, Acting Deputy Director
Office Telephone: 240-506-7567
Email: rebecca.dowd@fda.hhs.gov 

What We Do

  • The Drug Quality and Sampling and Testing Program (DQST)
    The DQST program is an integral part of the FDA’s post-market surveillance program. DQST covers prescription drug products, over-the-counter drug products, and active pharmaceutical ingredients. It includes domestic and foreign manufacturers for products distributed in the U.S market. 

    The objective of the DQST program is to assess drug product quality through a risk-based sampling and testing assignments to aid the detection of drug substances and drug products that may pose quality and safety risks to the U.S patients and consumers.

Report a Product Problem Through SmartHub

SmartHub

The FDA’s SmartHub is designed to help the public navigate to the appropriate form or resources to report a problem with an FDA regulated human or animal product (e.g. defects in the quality or safety of a product, or labeling issue), adverse health experience (e.g. injury, illness, or death associated with a product), or facility issue (e.g. an FDA regulated facility issue such as a whistleblower report or sanitation issue).

 



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