FDAImports.com

04/26/2023

Benjamin L. England & Associates is proud to announce obtaining the successful modification of a CBP Withhold Release Order (WRO) that banned the Smart Glove Group’s disposable gloves manufactured in Malaysia from entry into the U.S. due to forced labor concerns. The import ban has now been lifted, and shipments of gloves manufactured by the Smart Glove Group received on or after April 26, 2023, will no longer be denied entry to the U.S. This is the fourth modification of a CBP forced labor enforcement action obtained by Benjamin L. England & Associates.

Jessica Rifkin, our Customs, Trade, and Litigation team lead stated, "This outcome is a direct result of the extremely hard work and perseverance of our client Smart Glove and our Customs and Trade team. Our extensive experience in this area allowed us to effectively represent and aid our client to address CBP’s concerns and resolve this matter fully."

Benjamin L. England & Associates, LLC is proud to announce obtaining the successful modification of a CBP WRO that banned the Smart Glove Group’s disposable gloves manufactured in Malaysia from entry into the U.S. due to forced labor concerns.

04/25/2023

Yesterday, FDAImports.com sister law company (the law firm of Benjamin L. England & Associates - BLEA) proudly announced that its attorneys and regulatory staff will join the law firm of Olsson Frank Weeda Terman Matz PC (OFW Law) on May 1st! FDAImports will continue to operate separately, providing the same regulatory consulting and registration services as it has for over 15 years, led by its owner, Benjamin England.

You can rest assured that you can still count on FDAImports to continue providing its same great regulatory services such as Facility and product registrations & listings, U.S. Agency services, State Petfood AAFCO registrations, FDA FSVP importer services, FDA medical device initial importer/distributor services and USDA APHIS/PPQ Permit holder services. FDAImports will continue to work just as closely with the same experienced BLEA staff who, as of May 1, 2023, will reside at OFW.

Please read our full announcement for any further questions: https://hubs.la/Q01MKDRT0

We look forward to our continued growth!
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FDAIMPORTS.COM’S SISTER LAW FIRM BLEA MERGES WITH OFW TO CREATE POWERHOUSE TEAM OF FDA USDA CBP and LITIGATION DEFENSE

04/05/2023

In early 2023, FDA sent notices to food facilities not in compliance after their initial UFI validation, advising them to correct the inconsistencies for successful UFI validation and the continued validity of their registration. This notice allowed facilities an additional 60 days to rectify the issue.

FDA has now begun notifying food facilities that have failed to comply within the timeframe provided in their notice that their registration has been canceled. They have advised that the registrations can be reinstated upon request after necessary corrections have been made.

Any facility that has received this email from FDA should take action to confirm that the information on their facility registration is consistent with what is listed in the Dun & Bradstreet database.

FDA has now begun notifying food facilities who have failed to comply within the timeframe provided in their notice that their registration has been canceled.

03/27/2023

FDA withdrew approval of 11 abbreviated new drug applications (ANDAs)

https://hubs.la/Q01DYVLs0

03/24/2023

FDA announced a discussion paper soliciting public comments on advanced manufacturing technologies. The paper presents policy development identified by CDER scientific and policy experts associated with artificial intelligence (AI) to pharmaceutical manufacturing.

https://hubs.la/Q01DYYWC0

03/22/2023

FDA is requesting nominations for voting members to serve on the Patient Engagement Advisory Committee in the Center for Devices and Radiological Health.

https://hubs.la/Q01DYPHm0

03/20/2023

FDA filed a petition, submitted by Innophos, Inc., proposing that the color additive regulations be amended to provide for the safe use of tricalcium phosphate in poultry (chicken thigh), icing, white chocolate candy melts, doughnut sugar, and sugar for coated cadies.

https://hubs.la/Q01DDrjQ0

03/17/2023

FDA announced a draft guidance entitled “Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.” This guidance provides recommendations to sponsors developing drugs intended to treat neovascular age-related macular degeneration - focusing on eligibility, trial design, and efficacy endpoints.

https://hubs.la/Q01DDrW80

03/15/2023

FDA announced an opportunity for public comment on the proposed collection of information associated with current good manufacturing practice (CGMP) for blood and blood components related to reducing the risk of transfusion-transmitted infection (TTI).

https://hubs.la/Q01D1pfD0

03/13/2023

If you are at Seafood Expo North America 2023 join us today at 11:45 am to see Ben England, Jessica Rifkin and representatives from CBP discuss, "Customs Compliance and Enforcement: Forced Labor and the UFLPA."

This session will provide an in-depth exploration of CBP compliance and enforcement issues in the forced labor area. Hear from CBP officials on what to expect in 2022, what they think is important and why. Pick up some pointers on what seafood importers should be doing to avoid having their imports barred from entry due to forced labor concerns.

This session will provide an in-depth exploration of CBP compliance and enforcement issues in the forced labor area. CBP’s focus on “traditional” forced labor enforcement actions has increased in recent...

03/10/2023

begins on Sunday! If you are going to be at the show, stop by Booth 769 or come check out Ben England and Jessica Rifkin discuss "Customs Compliance and Enforcement: Forced Labor and the UFLPA" with CBP officials. We are so excited about another great year in Boston and hope to see you there!

03/08/2023

FDA announced an opportunity for public comment on the proposed collection of information associated with medical device premarket notification (510(k)).

https://hubs.la/Q01D1php0