1. Office of Regulatory Affairs Division of Southwest Imports

2. Southwest Region/SWID
SWID Investigations Branch supervisors are located throughout the states of California, Arizona and Texas.
Ten are ‘border’ supervisors and the remaining two are ‘inland’ port supervisors. Currently, we have a total of 91 investigators/inspectors.
SWID Compliance Branch officers are located in San Diego, Laredo and Dallas.
Currently, we have a total of 13 compliance officers.
All shipments of FDA-regulated products are reviewed by FDA and must comply with the same standards as domestic products.  FDA determines whether products are admissible into U.S. commerce and may refuse entry to any that violate or appear to violate any provisions of the Food Drug and Cosmetic Act (FD&C Act).
Reference:
Import Program

3. Contact Information
U.S. Food and Drug Administration Southwest Import District 
4040 N. Central Expressway, Suite 300
Dallas, TX
Phone: (214)
Fax: (214)
Sylvia Gaytan: Public Affairs Specialist
(214)
Todd Cato - District Director Stacy Below - Investigation Branch Alex Lopez - Compliance Branch

4. Entry Lines by FDA Industry Codes
The parameters used were Industry Code and Submission Dates for calendar year 2015 (Jan – Dec), and the output used was Line Counts.
Biologics (Industry Code 57): 156,808 lines
Cosmetics (Industry Code 53): 3,029,103 lines
Dietary Supplements (Industry Code 54): 358, 767 lines
Devices (Industry Codes 73-91): 16,791,459 lines
Drugs (including finished dosage and APIs) (Industry Codes 55,56, 60-66): 704,522 lines
APIs (Industry Codes 55, 56, with PIC S or T): 40,140 lines
Food (including seafood and produce): 14,888,595 lines
Produce (Industry Codes 20, 21, 22, 24, and 35 with PIC B, C, or D): 3,361,196 lines
Seafood (Industry Code 16): 11,148,855 lines
Tobacco (Industry Code 98): 16,062 lines
Total Lines: 37,354,550 lines of FDA-regulated products
Reference: DIO-IOMB, Elizabeth Dahl (8/9/16)

5. Investigations Branch
Determine admissibility of products regulated by FDA
Conduct investigations and inspections
Examine and collected imported products
Investigations on substituted product, either at the time of entry or following a refusal of admission, have lead to numerous CBP seizures and issuance of civil money penalties. SWID also conducts work associated with outbreaks including both tracebacks and recalls.
FDA conducts inspections of foreign facilities exporting goods to the U.S., conducts inspections of importers such as seafood HACCP inspections, and partners with other federal and state government agencies to complete its public protection mission. At the forefront of these efforts is the import enforcement initiative. This initiative relies on joint cooperation between US Customs and FDA to prevent the importation and distribution of violative goods to the American public. These cooperative efforts seek to enhance enforcement activities against those individuals and companies that are engaged in fraud, smuggling, and other illegal actions designed to circumvent FDA and Customs authority.

6. Compliance Branch Traditional Enforcement Detentions Refusals
Import Alerts
Inspections
Recalls
Joint FDA/U.S. Customs
Title 19 Seizures
Title 19 Civil Money Penalties
Broker Penalties
Section 801 of the Federal Food Drug and Cosmetic Act gives U.S. Customs and FDA broad regulatory authority for preventing the importation of violative products.
The ‘traditional’ FDA import enforcement tool is as follows:
If, following examination, a product “appears” to be violative, FDA may issue a detention notice specifying why the product appears to be violative.
The importer has 10 working days to either show that the product is not violative, correct the deviations, or render it a non-FDA regulated product.
If after this period, FDA determines that the product is still violative, a refusal of admission is issued. Following the refusal of admission, US Customs will demand redelivery of the violative goods for exportation or destruction.
The development and use of import alerts allows the detention of future entries of a product based on information gathered by FDA that indicates the product “appears” to be violative.
The Southwest Import District Compliance Branch consists of a Branch Director, Special Assistant, 13 compliance officers, a Legal Instrument Examiner, and two Consumer Safety Technicians . The compliance staff of the Southwest Import District performs many traditional FDA import enforcement actions. Import issues have grown in importance and volume as more FDA regulated products are produced and shipped from foreign sources. The number of imported products is projected to continue growing for the foreseeable future.  Imported products cover the full range of FDA regulated commodities, are increasingly entered in a finished ready to use state, and present a unique challenge to determining compliance with US laws and regulations. 
SWID compliance staff work extensively with all FDA product centers, U.S. Customs, and the FDA Office of Criminal enforcement.  SWID compliance officers also have extensive contact with regulated industry as they evaluate evidence and consider enforcement actions with regards to imported products.
As the industry has changed, import actions have also grown beyond the traditional detention/refusal/private lab assessment scenarios. SWID compliance officers routinely recommend seizures, civil money penalties, and broker penalty actions in cooperation with Customs.  SWID compliance officers also work with FDA Office of Criminal Investigations (OCI) in building criminal cases in the import arena.

7. FSMA
FSVP
FSMA Sampling Assignments

8. FSVP challenges Finding the FSVP Importer
Who is the FSVP Importer…”It’s not me”
wrong address, no office, or no staff???
FDA will launch an investigation
Pre-Inspection call is very important
No appointments

9. FSVP FINDINGS NAI; VAI; OAI Majority have no FSVP
Or have only pieces of FSVP
Provide Foreign Supplier FSMA plan
Most seem not to understand they need their own FSVP records/documents

10. WHAT’S WORKING FSVP Outreach Educate while we regulate
Industry seems willing to comply

11. Testing the Food Supply to Support FSMA
Under the new sampling approach, the FDA is collecting a statistically determined number of samples of targeted foods over a shorter period of time—12 to18 months:
-Sampling targets both domestically produced and imported food
-Represents what consumers are likely to find in the market place
-The data will be used for future decision making

12. How will the agency use the data:
Decreasing sampling, if few positive samples are obtained
Implementing more targeted sampling for example,
if positive samples come from:
a specific geographic region
a specific facility
during a particular season

13. How will the agency use the data cont:
Follow-up inspections
Working with state or international regulatory partners to take corrective actions and implement preventive controls
Developing new or enhanced industry guidance
Conducting outreach and information sharing to better protect consumers
Follow-up to positive results includes potential regulatory actions

14. Avocado Assignment 1600 changed to 1200 samples to be collected
Processed avocado and guacamole
Domestic and Import Samples
History of outbreaks including Salmonella and E. Coli

15. Fresh Herb Assignment Fresh cilantro, parsley and basil
1600 samples will be collected
Both domestic and import samples
History of outbreaks including Cyclospora, E. coli and Shigella
Also testing for Salmonella

16. Timeframes Timeframes for Produce: Investigations Analytical
Compliance
Expanded hours of operation

17. QUESTIONS?