FDA Los Angeles District Office 10th SABPAocla.sabpa.org/2015forum/Presentation files... · FDA Los...
Transcript of FDA Los Angeles District Office 10th SABPAocla.sabpa.org/2015forum/Presentation files... · FDA Los...
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FDALos Angeles District Office
10th Annual Biomedical ForumSABPA
Import/Export Challenges and Guidance for FDA Medical Products
April 25, 2015
Dan Solis, DirectorLos Angeles District Import Operations
U.S. Food and Drug Administration
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FDA AUTHORITIES
Office of Regulatory Affairs
Center forFood Safety &Applied Nutrition
Center forDrug Evaluation &Research
Center forBiologics Evaluation &Research
Center forDevices &RadiologicalHealth
Center forVeterinaryMedicine
NationalCenter forToxicologicalResearch
Center forTobaccoProducts
Office of International Programs
Office of Chief Scientist
OFFICE OF GLOBALREGULATORY
OPERATIONS &POLICY
OFFICE OF FOODS and FEED
OFFICE OF MEDICAL PRODUCTS &
TOBACCO
OFFICE OF OPERATIONS
OFFICE OF REGULATORY
AFFAIRS
Office of International
Programs
Center for Food Safety & Applied
Nutrition
Center for Veterinary Medicine
Center for Devices &
Radiological Health
Center for Drug
Evaluation & Research
Center for Biologics
Evaluation & Research Center for
Tobacco
Office of Special Medical Programs
National Center for
Toxicological Research
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FDA Regional Field Office – Pacific Region
Regional Field OfficeOakland, Ca
Los Angeles District Office
Irvine, Ca
San Francisco District OfficeAlameda, Ca
Seattle District Office
Bothell, Wa
Pacific Regional Lab North-WestBothell, Wa
Pacific Regional Lab South-West Irvine, Ca
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FDA Los Angeles District
Los Angeles District OfficeIrvine, Ca
Import Operations
(Port Operations)
Long Beach, Ca
Domestic Investigations
Irvine, Ca
Compliance Branch
Irvine, Ca
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FDA Import Operation MissionPrevention and Investigation of
Adulterated, Unapproved and Misbranded FDA
Products from coming into the United States.
Import Product Review• Entry Review (PREDICT)• Field Examinations• Product Sample Collection• Investigations
Inspections• Establishment Inspections • Facility Inspections • Importer Inspections
Investigations• Consumer Complaints• Emergency Response• Smuggling Investigations
RecallSeizure of Products at the Border
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MAIN IMPORT OPERATIONS OFFICE – Long
Beach, CA
LOS ANGELES AIRPORT – LAX
CENTRALIZED EXAMINATION
STATIONS (CES) 4 -PRICE TRANSFER, FCL,
CAL CARTAGE
Woodland Hills Resident Post –Woodland Hills,
Ca
ONTARIO AIRPORT Resident Post – Ontario, Ca
International Mail Facility (IMF) –
Torrance, Ca
Phoenix Airport–Phoenix, AZ
FDA LOS-DO IMPORT OPERATIONS
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Airport
Airport
Airport
Airport
LOS ANGELES
FLORIDA
DOWNSTATE NEW YORK
UPSTATE NEW YORK
SOUTH WEST IMPORT DISTRICT
IMPORT BRANCHES AND DISTRICT
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Airport
LOS ANGELES
IMPORT PROCESS
CBP FDA
IMPORTATION INTO THE UNITED STATES
REFUSEDDESTROYED
EXPORTED
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foodsProduct info, Firm info,
Country of Mfr. Info, Consignee
Entry filer Customs
OASIS
IMPORT PROCESS
Review?No
FDA district entry reviewer
Yes
DIVISION OF FOOD
DEFENSE
TARGETING (DFDT)
OK?Yes No“May proceed”
message“FDA review”
message
PN screening – food
801(a) screeningPREDICT
othersfoods
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FDA district entry reviewer
Entry filer
Initial action?
Field exam
Sample, analyze
Compliance Officer (Hearings
Officer)
“May proceed”message
Results?
Complianceaction
Detain w/ophysical exam
Detain/Refuse
Set Up Assignments or Investigations
Release
Good
Documentsrequestedby FDA
Bad
IB release
???
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PREDICT AT FDA(PREDICT) - Predictive Risk-based Evaluation for Dynamic Import
Compliance Targeting• Risk assessment tool – Improves screening and targeting• Assesses relative risk of FDA Regulated Products, comparability of
country, intelligence, data mining• Increases speed of FDA releases for low risk foods/compliant products;
reduce sampling and exams• Prioritizes higher risk FDA regulated shipments - increase sampling and
exams• MARCS Entry Review and PREDICT were first deployed in Los Angeles
District. Now all FDA Districts are using PREDICT.
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PREDICT method
• Use automated data mining and pattern discovery
• Utilize open-source intelligence
• Provide automated queries of Center databases where relevant (i.e., registration and listing, marketing approval status, low-acid canned food scheduled processes, etc.)
• Learning algorithm to adjust for future shipments
• Provides information from other ports.
PREDICT LINK
Special Rules for Drugs• Foreign drug firms are required to register their
establishments, and list their products, with the FDA. The required forms (FDA-2656 {Registration of Drug Establishments} and FDA-2657 {Drug Product Listing}) can be requested from the Center for Drug Evaluation and Research, Records Repository Team (HFD-143), 5600 Fishers Lane, Rockville, MD 20857.
• Drugs are restricted from importation unless they are covered under an Investigational New Drug Exemption (IND) or by an approved New Drug Application (NDA). Information on regulations covering INDs or NDAs and application forms should be requested from CDER Executive Secretariat (HFD-8), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857.
Special Rules for Devices• Devices must meet FDA regulations prior to the
importation of medical devices into the United States. FDA does not recognize regulatory approvals from foreign countries/areas.
• If your device is a type that requires a premarket notification (or 510(k)) submission, you are required to submit a 510(k) when the following occurs: (a) a foreign manufacturer intends to export a medical device to the U.S. that the firm has never before shipped to the U.S.; (b) either the foreign manufacturer or initial distributor changes the intended uses of devices that are legally being marketed in the U.S.; or (c) changes or modifications to a legally marketed device that could significantly affect its safety or effectiveness. Information on how to submit a 510(k) is available athttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.
Special Rules for Devices• All foreign firms are required to both register their establishments, identify a
U.S. Agent, and individually list their devices before they may import them into the United States. Complete information on registration and listing requirements and processes can be obtained from the Registration & Listing website, or by contacting DICE as described below.
• Form FDA 2877 (Declaration for Radiation Standard) http://www.fda.gov/opacom/morechoices/fdaforms/FDA-2877.pdf is required for radiation-emitting electronic products entering the United States.
• Information concerning premarket notification, radiation control standards, or device listing and establishment registration, is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm You may also contact the Center for Devices and Radiological Health, Division of Industry and Consumer Education (DICE), 10903 New Hampshire Avenue, WO66-4613, Silver Spring, MD 20993-0002, (800) 638-2041. Manufacturers outside the U.S. should call: (301) 796-7100. Email [email protected]
Submission of Documents
• Documents can be submitted by– Word, Pdf, Excel, Common picture files
• When submitting availability of goods for examination, the user may indicate that the goods are located by the consignee as filed in the FDA entry, or another location as entered by the user.
Benefits of ITACS• The ability to submit documents electronically
– Reduces the need for phone calls– Increases predictably by reducing dependence on
faxes and courier delivery• ITACS can be accessed by
https://itacs.fda.gov– Need a valid customs entry number that has been
transmitted to the FDA– In the future, login accounts are planned and FDA
will be able to query FDA firm identifiers and product codes and communicate with FDA.
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Learn More About ITACS
• Take a tutorial –http://www.fda.gov/forindustry/importprogram/ucm296314.htm
• Do not contact the Districts directly about ITACS
• To report problems or ask questions, please send emails to: [email protected]
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OGA RelationshipsFDA
FOREIGN GOVERNMENTS
CALIFORNIA FDB
LA COUNTY PUBLIC HEALTH
LAPD VICE DIVISIONDEA(Drug Enforcement Administration)
FWS(Fish and Wildlife Service)
US POSTAL INSPECTORS
CBP (CUSTOMS AND BORDER PROTECTION)
HSI (Homeland Security Investigations)
CALIFORNIA DEPT. OF FOOD AGRICULTURE
SHARE THE SAME COMMON GOAL: PROTECT PUBLIC HEALTH
CALIFORNIA DEPT. OF PESTICIDES REGULATION
CA Board of Pharmacy
LA CITY ATTORNEY’S OFFICE
US Dept. of Agriculture (USDA – SITC, FSIS, Aphis, Agri)
CPSC(Consumer Product Safety Commission)
LA CITY FIRE DEPARTMENT
ORANGE COUNTY and Los Angeles DA’s OFFICE
LA DISTRICT ATTORNEY’S OFFICE
NOAA(National Oceanic and Atmospheric Administration )
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FDA’s New Legislations
• Food Safety Modernization Act (FSMA). Signed into law on January 4, 2011. The most sweeping reform of our food safety laws in more than 70 years. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.– Seven Proposed Rules right now:
• Produce Safety (Jan-2013)• Preventive Controls for Human Food (Jan-2013)• Foreign Supplier Verification Program (FSVP) – (Jul-2013)• Accreditation of third-party auditors for foreign facilities (Jul-2013)• Preventive Controls for animal foods (Oct-2013)• Mitigation for Intentional Adulteration of Food (Dec-2013)• Sanitary transportation of human and animal food (Feb - 2014)
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FDA’s New Legislations• The Family Smoking Prevention and Tobacco Control Act (TCA).
Signed into law on June 22, 2009. Gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. Aims to curb the trend of new users becoming addicted before they are old enough to understand the risks and ultimately dying too young of tobacco-related diseases.
• Food and Drug Administration Safety & Innovation Act (FDASIA). Signed into law on Jul. 9, 2012. Expands the Agency’s authorities and strengthens the agency’s ability to safeguard and advance public health by giving the authority to collect user fees, promoting innovations, increasing stakeholder involvement and enhancing the safety of the drug supply chain
– Prescription drug provisions (PDUFA V)– Medical Device Provisions (MDUFA III)– Generic Drug User Fee Amendments of 2012 (GDUFA)– Biosimilar User Fee Act (BsUFA)
• Drug Quality and Security Act (DQSA). Signed into law on Nov. 27, 2013. Outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S.
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Import Alerts • Import Alerts = are public alerts on FDA
products that the Agency has concerns about being Imported into the United States. Information on manufacturers, products and importers are provided as well as guidances.
http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm
Best Practices• Submission of proper manufacturer information
and address (Good history speeds through entry process)
• Submit correct AofC and hire a competent Customs Broker
• Study Import Alerts and Product requirements –if unsure talk to consultants
• Cooperate with FDA Investigators and submit info ASAP (other wise back to end of line)
• Wait a couple of days after submission before calling a Compliance Officer and know your Entry Number (case number) 24
Best Practices• Email and a follow up phone call for lengthy discussions
needed• Have goods available for FDA Appointments• Be honest with Compliance Officer if error was made• Have all records and documents ready to show if product
is registered – keep all lab analysis results• Do homework on www.FDA.gov website• Do not release goods until you receive the FDA Notice to
“May Proceed”• Cooperate and comply with time frames and directions
from the Compliance Officer
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Common Mistakes• Wrong manufacturer information, address, MID and FEI
numbers• Does not know process and procedures to follow• Calls all FDA extensions• Emails more than 4 FDAers• Demands FDA to release shipments• Falsifying documents – Title 18 • Ignoring FDA Notice of Actions• Ignoring CBP summons and penalty notices• Sells adulterated products into commerce• Does not cooperate with recall coordinator• Submits after the Detention notice due date• Ask FDA to rescind a Refusal 26
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FORMS OF COMMUNICATION WITH FDA in LOS ANGELES IMPORTS
• Phone Numbers for LOS-DO Import Operations (Long Beach, Ca)– General status line (562) 256-7700– Compliance status line (562) 256-7707– Fax line (562) 256- 7701
• General email address: [email protected]• LAX Office email address: [email protected]• Los Angeles District Consumer Complaint Hotline: (949) 608-3530• FDA National Emergency Operations Number: 1-866-300-4374 • FDA General Inquiry: 1-888-INFO-FDA • For Adverse Event of illness call 1-800-FDA-1088 or online• For Drug Inquiries: [email protected] or (866)-405-5367• For Medical Device Inquiries: [email protected] or (800) 638-
2041Note: Fastest response is email.
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Email address: [email protected]
Thank You For Your Attention!
Thank you for comingfor your interestfor taking responsibilityfor your diligence and accuracyfor using this informationfor sharing this informationfor educating yourself via
www.fda.gov