WARNING

REcall

Fine

imports

Protecting Public HealthOffice of Regulatory Affairs (ORA)ORA Fiscal Year 2017

ORA Facts ORA Maximizes Compliance of FDA Regulated Products

and Minimizes Risks Associated with Those Products State 

Cooperative  Official  State Administrative  States­ Programs ­  Establishment  Operational Contracts,  Consumer

& Mission  Standard  Milk, Retail,  State  Inventory  Policy Grants &  Complaint  ExecutiveORA Employees Support Programs Shellfish Liaisons Coordinators Analysts Agreements Coordinators Leadership

ORA At A Glance~5,000

Civil &  Emergency  13  Quality  Recall  Training,  Disclosure  Compliance  Import  Communications Criminal  Response  Laboratories Systems  Coordinators Education  & FOIA Officers Operations Staff

Managers & Development Investigators Coordinators Staff

Regulatory and Public Health Partnerships Expanded our federal, state, local, tribal and territorial regulatory and public health partnership efforts

139 contracts awarded 290 cooperative agreements and 

for a total of $25.3 million  grants for a total of $85.5 million

Inspections: ORA's Global Reach

ORA's Global Inspections:

Argentina Estonia Lithuania SpainAruba Finland Malaysia Sri LankaAustralia France Malta SwedenAustria Georgia Marshall Islands SwitzerlandBelgium Germany Mexico TaiwanBelize Greece Netherlands ThailandBolivia Grenada New Zealand Trinidad & TobagoBosnia-Herzegovina Guatemala Nicaragua UkraineBrazil Hong Kong SAR Norway United Arab EmiratesBulgaria Hungary Panama United KingdomCanada Iceland Peru United StatesCayman Islands India Philippines UruguayChile Indonesia Poland Vietnam China Ireland PortugalColombia Israel RomaniaCosta Rica Italy RussiaCroatia Jamaica SerbiaCzech Republic Japan Singapore Countries Where Denmark Jordan Slovakia ORA PerformsDominican Republic (the) Korea (the Republic of ) Slovenia Inspections Ecuador Latvia South Africa

Inspections Enforcement

39,513Total Inspections

15,318Warning Letters Issued

16,577 Domestic Inspections

3,776  Foreign Inspections

19,160State Inspections

*Includes 14,875 warning letters issuedby the Center for Tobacco Products

9,199Recalled Products 45,002

Samples Collected & Analyzed

A line is a distinct productwithin a shipment. A singleshipment may includemultiple lines.

40,018,795Import Lines

Criminal Investigations

283OCI Arrests

226OCI Convictions

312Injunctions

243

Seizures

Allow FDA to detain futureshipments of potentiallyviolative products withouttesting or examination

Import Alerts

$205,048,648     OCI Assets Forfeited and Seized

$461,432,091OCI Fines and Restitution 

Published February 2018