Maridalia Torres District Director San Juan District Office Office of Regulatory Affairs Food and Drug Administration San Juan District Update “Protecting consumers and enhancing public health by maximizing compliance of FDA-regulated products and minimizing risk associated with those products”

2  Inspections  Pre approval  Post market  GMP  For-Cause  Surveillance  Investigations  Consumer Complaints  Emergency Response  Adverse Events  Confidential informants  Sample Collection and Analysis  Import Product Review  Field Exams  Sampling Responsibilities - District Office

3  Enforcement and Compliance activities: Advisory actions: Warning Letters, Untitled Letters Advisory actions: Warning Letters, Untitled Letters Judicial actions: seizure, injunction, prosecution Judicial actions: seizure, injunction, prosecution Regulatory Meetings Regulatory Meetings Imports: Release, Detention, Reconditioning, Refusal, Bond & Penalty Actions (CBP) Imports: Release, Detention, Reconditioning, Refusal, Bond & Penalty Actions (CBP) FAR’s & Recalls FAR’s & Recalls Public Affairs Public Affairs Collaboration/Leveraging (Local, State, Federal) Collaboration/Leveraging (Local, State, Federal) State Contracts/Partnerships State Contracts/Partnerships Laboratory: Sample Analysis, Research, Method Development Laboratory: Sample Analysis, Research, Method Development

4 COMMISSIONER FOODSDRUGSDEVICESVETBIOLOGICSTOBACCO FDA Centers & FDA Field ORA (FIELD)

5

6 Southeast Region – Atlanta, GA Four Districts Four Districts Atlanta Atlanta GA, NC, SC GA, NC, SC Florida Florida FL FL New Orleans (Nashville) New Orleans (Nashville) TN, AL, MS, LA TN, AL, MS, LA San Juan San Juan PR, USVI PR, USVI

7 District Office Composition District Director’s Office District Director’s Office Administrative Branch Administrative Branch Investigations Branch Investigations Branch Compliance Branch Compliance Branch Science Branch (6 Districts) Science Branch (6 Districts)

8 HQ/QM&SJN-DSB

9 DDO/HQ

10 Virginia L. Meeks Director Investigations Branch Cecilia Rolon Consumer Safety Technician Rebecca Rodriguez National Drug Expert, DFI Vacant Consumer Complaint Coordinator Ramon Hernandez Pre-Approval Manager Vacant (2) Supervisory CSO Jose Melendez (Drug Specialist) Nancy Rosado (Food Specialist) Rebecca Parrilla (Drug Specialist BIMO Coordinator) Luz Rivera Maribel Juarbe Juan Jimenez Milva Melendez Eva Mered Annette Melendez Vacant, CST St. Thomas Resident Post Raymond Lyn Jose F. Pedro, Supervisory CSO Jaime Pares (Food Specialist) Wanda Torres, (Device Specialist) Frances de Jesus, CCO Jorge Lajara Anita Rivera José R. López Marylin Santiago Libia Lugo Zuleika A. Piñeiro Rafael Gonzalez Annette Melendez Geneive Llera, CST Maria Ruttell, Supervisory CSO Jose A. Cruz (Drug Specialist) Lourdes Andujar Laura Garcia, CCO Pablo Feliciano Noreen Muñiz Adaliz Santaliz Ponce Resident Post Karl Hezel Laiza Garcia Dayna Martinez Leslie Mendoza, CST Plus 5 additional CSO’s coming on board 2010

11 Edwin Ramos Director Compliance Branch Vacant Recall Coordinator Carlos I. Medina Compliance Officer Margarita Santiago Compliance Officer Rafael Nevarez Compliance Officer Imports Carlos A. Medina Compliance Officer Mariluz Otero Mayra Burgos Legal Instrument Examiners Vacant FOI Specialist

12 Teresa Franco Administrative Officer Ivette Roque Administrative Support Assistant (HR) Vacant Administrative Support Specialist (Purchasing) Wilford Martinez Administrative Support Specialist (Budget) Marilyn Fontanez (Student) Reception/File

13 ORA FTE History

14 Domestic & Import Investigator Experience Levels: 44% have less than 2 years experience Under 1 year37% 1-2 years 7% 2-5 years 3% 5-10 years26% 10+ years18% Retirement % Updated August 1, 2009

15 ORA FTEs – FY’10

16 SJN FTEs – FY’10

17 Regulated Industry in PR There are 1,486 FDA-regulated establishments in Puerto Rico

18 Operational Workload Obligations Operational Workload Obligations Driven by Performance Goal Obligations and Congressional Mandates Driven by Performance Goal Obligations and Congressional Mandates Driven by Centers Driven by Centers Driven by Official Establishment Inventory Driven by Official Establishment Inventory Driven by Risk Factors Driven by Risk Factors Performance Goals- Risk Driven Site Selection of Registered Establishments Performance Goals- Risk Driven Site Selection of Registered Establishments Workplan Obligations- Driven by Centers Workplan Obligations- Driven by Centers Operational Workload

19 SJN Operational Workload- CDER 2010 Workplan Obligations 2010 Workplan Obligations ForeignDomestic BIMO 0 2 BIMO 0 2 PAI PAI GMP + Post Approval GMP + Post Approval PG Obligations 2010 PG Obligations Domestic HR GMP EI’s27 Domestic HR GMP EI’s Congressional Mandates 2010 Congressional Mandates Import Drug Field/Label Exams70 Import Drug Field/Label Exams70 Domestic Drug Post Approval EI’s58 Domestic Drug Post Approval EI’s58

20 Natural Disasters Natural Disasters Food borne Outbreaks Food borne Outbreaks Spinach/Lettuce/Carrot Juice/Peanut Butter Spinach/Lettuce/Carrot Juice/Peanut Butter Botulism Botulism Castleberry- Chili sauce, others Castleberry- Chili sauce, others New Era- Green Beans New Era- Green Beans Melamine in Pet Food Melamine in Pet Food Heparin Heparin DEG in Toothpaste, Cough Syrup, others DEG in Toothpaste, Cough Syrup, others Complaints, Recalls, CI, Adverse Events Complaints, Recalls, CI, Adverse Events Tobacco Tobacco Other Drivers

21 Congressional Mandates In FY08 and FY09 budgets, Congress mandated the following increases for ORA: In FY08 and FY09 budgets, Congress mandated the following increases for ORA: 850 additional foreign food and feed inspections; 850 additional foreign food and feed inspections; 1,862 additional domestic food and feed inspections; 1,862 additional domestic food and feed inspections; 40,000 additional food and feed import field exams; 40,000 additional food and feed import field exams; 250 additional medical product foreign inspections; 250 additional medical product foreign inspections; 250 additional medical product domestic inspections; 250 additional medical product domestic inspections; 10,000 additional medical product field exams. 10,000 additional medical product field exams. Domestic and import increases will be reached in FY10, with the exception of the domestic food inspections. Domestic and import increases will be reached in FY10, with the exception of the domestic food inspections. Foreign increases will be reached in FY11 Foreign increases will be reached in FY11 100% increase in Foreign Inspections in 3 years

22 FDA/Office of International Programs To make better decisions regarding the quality, safety and effectiveness of products destined for the US market. To make better decisions regarding the quality, safety and effectiveness of products destined for the US market. Enhance collaboration/leveraging, harmonizing regulations, technical cooperation Enhance collaboration/leveraging, harmonizing regulations, technical cooperation China Office: Beijing, Shanghai, Guangzhou China Office: Beijing, Shanghai, Guangzhou India Office: New Delhi, Mumbai India Office: New Delhi, Mumbai Europe Office: Brussels, London, Parma Europe Office: Brussels, London, Parma Latin America Office: San Jose, Santiago, Mexico City Latin America Office: San Jose, Santiago, Mexico City

23 FDA Commissioner’s Vision on Enforcement Six initial steps to improve effectiveness and timeliness of FDA’s regulatory and enforcement system: Six initial steps to improve effectiveness and timeliness of FDA’s regulatory and enforcement system: Set-post-inspection deadlines. Set-post-inspection deadlines. Take responsible steps to speed the WL process. Take responsible steps to speed the WL process. Work more closely with FDA’s regulatory partners. Work more closely with FDA’s regulatory partners. Prioritize follow-up on WL & other enforcement actions. Prioritize follow-up on WL & other enforcement actions. Be prepared to take immediate action in response to public health risks. Be prepared to take immediate action in response to public health risks. Develop and implement a formal WL “close-out” process. Develop and implement a formal WL “close-out” process.

24 Other Initiatives Quality Management Quality Management Upgrades in Technology Upgrades in Technology Improved Communications Improved Communications Risk Control Review Pilot Risk Control Review Pilot GMP OAI Pilot GMP OAI Pilot Knowledge Transfer Knowledge Transfer

25 ORA / SE Region Mission Statement Dedicated to Promoting and Protecting Public Health by Assuring Safe and Effective FDA Regulated Products