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
