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FDA

FDA entry reject? Could be a food facility registration issue…

Wednesday, February 15th, 2017

rejected

If your entry was subject to an FDA reject, perhaps the food facility involved was not properly registered.

Per CSMS #17-000078:

FDA invalidated food facility registrations that failed to renew during the 2016 biennial registration period. In addition, food facility registration were invalidated for failure of confirmation by a US Agent and/or foreign manufacturer (registered by a third party) as required under the FDA Food Safety Modernization Act (FSMA), Section 415 of the Federal Food, Drug, and Cosmetics Act (FD&C Act) [21 U.S.C. § 350D] and in accordance with 21 CFR 1.231(a)(5) and (b)(7). (Please see related CSMS message 16-001052). [And see our related blog post]

  • If you are receiving an entry rejection for an invalid registration, you will need to confirm the status of the registration with the manufacturer. The manufacturer may check the status of their registration by logging into their FURLS Food Facility Registration Module account to verify the status of the individual registration.
  • Registrations that have been invalidated cannot be renewed and a new registration will have to be created. The US Agent or the owner must confirm the receipt of the registration within 30 days for it to be valid in the FDA reference database.
  • Failure to have a valid registered manufacturer can cause a shipment delay greater than 24 hours, therefore it is not recommended to file a prior notice if the registration is pending or use a facility registration that was invalidated due to failure to renew or confirmed by the US Agent/Owner.

ACE information: For this reject the sub-reason code 112 is sent back in the SO transaction for entries, SO71 record. For Stand-Alone prior notice filings, in the PO transaction the code 112 is in the PO71 record.

  • Contact FURLS Registration Help Desk at FURLS@fda.gov or 800-216-7331 to verify the current status of the your Food Facility Registration. Please expect long wait times for phone calls.
  • Contact FDA ACE Support 24/7 at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries to determine the rejection reason.
  • Contact Division of Food Defense Targeting at prior.notice@fda.hhs.gov or 866-521-2297 for assistance with valid food registrations verified by FURLS Registration Desk that may be rejecting improperly.

Three new FDA import updates

Friday, February 10th, 2017

FDA has been and continues to be a very active PGA when it comes to ACE matters:fda1

 

1.  Submission of FDA data in ACE

As discussed in a previous blog post, CBP and FDA are working to implement changes related to FDA’s Final Rule on Submission of Food and Drug Administration Import Data in ACE  and corresponding Supplemental Guide. The first deployment occurred on January 5, 2017, and a second is to occur today.

2.  Common FDA rejects in ACE
In an effort to keep the trade community aware of how ACE is progressing for FDA transmissions, FDA has identified the most common FDA (bucket 2) rejects.• Invalid Product Code• Invalid Food Facility Registration Number• Mismatch between Food Facility Registration and Manufacturer

• Invalid state/zip code combination

• Foreign Consignee

• Duplicate Entry

• Missing or incomplete entity address

For specific information related to the various FDA error codes, please refer to FDA’s Error Guide.

3.  FDA Requirements Change for Medical Devices, IUC 081.005

The requirements for transmitting medical device constituent parts for drug-device IND combination products, Intended Use Code 081.005 have been changed.

The following Affirmations of Compliance for IUC 081.005 are now conditional: DEV, DFE, LST. These Affirmations of Compliance are in addition to DA and IND, which are already indicated as conditional. This change will be reflected in the next version of FDA’s Supplemental Guide

 

For questions on any of the foregoing, contact FDA ACE Support

ACE_Support@fda.hhs.gov or 877-345-1101 or 571-620-7320

LA trade professionals: Attend WITOC’s State of the Trade 2017 event

Tuesday, January 31st, 2017
Screen Shot 2017-01-30 at 3.16.41 PM 

Join Women In Trade — Orange County for its annual – The State of Trade – Symposium and Luncheon. Hear leading industry members and top local government officials provide a recap of 2016 and a look ahead of what to expect for 2017.

There will be speakers from CBP, FDA and CPSC that will present important industry updates that will affect all in 2017.

The lunchtime topic will feature a discussion of the different ways imports and exports will be affected by the 115th Congress and President-elect Trump.   Increase duties?  Tear up/renegotiate free trade agreements?  Border tax?  Trade war?  All will be discussed!

 

 

SPEAKERS:
Heather Litman, Trade Attorney
(Program Moderator)
Grunfeld, Desiderio, Leibowitz, Silverman & Klestadt
 
U.S. Customs and Border Protection
Anne Maricich, Assistant Director, Trade – Los Angeles Field Office
U.S. Consumer Product Safety Commission
Stacy Prosperi, Compliance Investigator, Office of Import Surveillance, Western Region
Food and Drug Administration
Dan Solis - Director of Import Operations LA District
EVENT DETAILS:
Date: February 15, 2017
Venue: Avenue of the Arts Hotel
3350 Avenue of the Arts
Costa Mesa, CA 92626
Cost:  Symposium - $120 Members ; $135 Non-Members
          Luncheon Only - $65 members ; $80 Non-Members
Registration after Feb.10, 2017, add $10 – No Cancellations or Refunds after Feb.13, 2017
register-now-button-pilll-red-hi

ACE: Free FDA webinar 1/31 to review Supplemental Guide 2.5

Thursday, January 26th, 2017

fda1

 

FDA and CBP will be hosting a webinar on Tuesday, January 31, 2017 from 1:00 pm – 3:00 pm Eastern Time to review updates to FDA’s Supplemental Guidance for ACE Version 2.5 and the related PGA Samples.  FDA will go over updates to the Implementation Guide that will go into Production on Thursday, February 9, 2017.  FDA will also address the trade’s questions during the webinar.

registernow

 

(Note: Registrants will also be able to submit questions in advance via the registration link.)

 

FDA/CBP webinar on FDA supplemental guidance for ACE on 12/13

Thursday, December 8th, 2016

FDA-Logo

 

 

FDA and CBP will host a webinar on Tuesday, December 13, 2016 at 2:30 pm Eastern Time.  The purpose of the webinar is to review updates to FDA’s Supplemental Guidance for ACE Version 2.5 and the related PGA Samples.  The link to the FDA Supplemental Guide and Samples will be posted to cbp.gov and a “Supplemental CSMS” will be issued with that link as soon as possible.

 

To participate in this webinar:

Join by phone

  • Local: 1-301-796-7777
  • toll free: 1-855-828-1770
  • Cisco Unified Meeting Place meeting ID: 745 429 430

Or click here and join by phone once you are on WebEx

 

ACE: CustomNow’s Nic Adams on FDA’s new final rule on import entry

Tuesday, December 6th, 2016

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The FDA just published a Final Rule in the Federal Register regarding requirements for the submission of information to the ACE.

It is now mandated that select data elements be submitted into ACE at the time of entry for FDA-regulated articles to include foods, human and animal drugs, medical devices, biological products, human cells, tissues, and cellular and tissue-based products (HCT/Ps), radiation-emitting electronic products, cosmetics, and tobacco products.

Nic Adams, Vice President of Client Services of CustomsNow, with over 30 years of strong customs compliance and global supply chain industry experience, adds the following commentary:

Nic Adams

Nic Adams

  • Much of the new rule is codifying the way things are today.  But it also shows the interplay between the FDA, who many would say did a ‘data grab’ with FDA message set, and the trade.  And, it clarifies the changes from the old process and the new.  Many are pretty exciting for us that have been battling/frustrated with the FDA for many, many years.
  • The fact that FDA is moving to a risk-based system is something the trade has been clamoring for over many years.  And to let the system make the determination in the majority of instances vs an FDA employee speeds things up greatly.
    • The average time for an FDA-reviewer to manually review and issue a “May Proceed” determination in ACS from August 27 to October 22, 2015, was about 28 hours and that has been reduced to under 2 hours in ACE
  • FDA rejected comments that it should make Device Listing Numbers (LSTs) publicly available, and decline to make the requested revisions to the requirement to submit the LST (i.e., permit the use of “UNK” instead of the LST).  This is problematic because importers often do not have access to this information at the time of entry.  But it appears that FDA erred on the side of keeping LSTS confidential: “The confidentiality of LSTs serves important public health interests and helps to prevent the importation of substandard, mislabeled, and counterfeit medical devices.”
  • It’s quite surprising that no one commented on radiation emitting devices.  I would have also requested that the registration information be made available to the public, but FDA probably would have used the same argument as they did with LSTs.
  • FDA has revised § 1.90 to allow FDA to provide notice of sampling directly rather than through the “collector of customs” which will normally happen through a secure electronic system.  No more waiting for your detention notice to show up in the mail!  Very nice.

 

 

 

Food importers: Avoid risk and create your Foreign Supplier Verification Program (FSVP) now!

Thursday, November 17th, 2016

produceUnder new FDA regulations, US food importers for the first time must ensure that imported food for humans and animal is as safe as domestically produced food.

Promulgated under the Food Safety Modernization Act (FSMA), the rules set parameters for foreign supplier verification programs (FSVPs) that importers must create and follow to safeguard the nation’s food supply.  Importers must have an FSVP program implemented by May 2017.

When the regulations were proposed in 2013, the FDA press release stated that

“[t]he new measures respond to the challenges of food safety in today’s global food system.  Imported food comes into the United States from about 150 different countries and accounts for about 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans.”

If you fail to comply with the new rules, it could result in disruption of your supply chain, delays in entry processing, and in some cases, the exclusion of your products from the U.S. marketplace.

Act now, since there is ”little time to design, test and implement a Foreign Supplier Verification Plan,” warned the FDA’s former Director of Import Operations Domenic J. Veneziano.  He also cautioned the new regulations are broad in applicability, “and include the actual CBP importer, as well as the owner or consignee of food being offered for import, and even the U.S. agent of the importer.”  Further, Veneziano noted that the rules apply to large and smaller importers, and you should check to see if you qualify for a specific exemption from the FSVP requirements.

 

 

 

The proposed rules also call for an accreditation program for third-party auditors of imported food.

ACE: instructions below for transmitting various FDA commodities

Friday, November 11th, 2016

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Per US Customs CSMS #16-000946:

Please follow the instructions below for transmitting various FDA commodities:

  • For Medical Devices (Government Agency Program Code “DEV”) only product codes with Industry Codes 73-92 are allowed in PG02.
  • For Radiation-Emitting Products, (Government Agency Program Code RAD) only product codes with Industry Codes 94-97 are allowed in PG02.
  • For Program Code animal-use devices, (Government Agency Processing Code “ADE”) only product codes with Industry Code 68 are allowed in PG02.
  • For Cosmetics, (Government Agency Program Code “COS”) only product codes with industry code 50 or 53 are allowed in PG02.

This information will be added to the next version of FDA’s Supplemental Guide.

Please direct any FDA ACE technical questions to ACE_Support@fda.hhs.gov.

 

How is ACE doing? Pretty well, it seems

Tuesday, October 18th, 2016

Here are some analytics on the state of ACE from US Customs’ September 2016 ACE Monthly Trade Update.  Of note:

  • Nearly 100% of ACE core capabilities have been deployed, with only 12% remaining for post-release functionality.
  • 3.4 million FDA cargo release entries were transmitted.
  • There were 62,000 active trade ACE portal users, up from 12,500 in FY15.

ACE_External_Adoption_Report_September_2016

 

 

 

 

CBP leveraging new ACE data tools to improve processes, risk management

Wednesday, October 12th, 2016

ace logo 2016

From our friends at the NCBFAA:

The ACE Business Office recently announced that the next focus of US Customs, as the remaining functionality of ACE is deployed, is how to best use the data tools that ACE provides.  The new technology will help CBP:

  • Facilitate processes
  • Promote more effective risk management
  • Keep moving towards goal of single window initiative

As for PGAs, the trade has noted that “more than 99 percent of goods inspected by some agencies are eventually let through, indicating that there’s room to improve targeting.”  However, there have already been notable improvements with FDA by having access to more import data via ACE:

  • Doubling of “may proceeds”
  • Decrease of document requests

Read the full article here.