FDA Hold Laser Detention

Below is sample:

  • Page 1-2. Customs release the shipment with (3461 and 7501) and importer pick-up the shipment
  • Page 3-4. But 2 month later, shipment was returned to vendor
  • Page 5-6. FDA officer gave, two choices returned to vendor and. . . . . . . . .
  • Page 7-9. Or destroyed here in us, under importer expense
  • Page 8-10. Importer contact freight forwarder/shipping-company to export back to vendor.
  • Page 11. Destroy notice or export back to supplier: (case# chiwpiua00r00) / epa-3520-1 entry has been denied on the vehicle because of the replacement engine / 1983 land rover engine was replace (was 2. 25l, replace with 2. 5l)

 

Example of FDA / U.S. customs detention for diode pump solar cell laser scribing machine, solar cell laser cutter importation: (Any thing with laser, FDA is automatically are in detention)

  1. U.S. customs will release shipment, but, there is still an released FDA hold. Cargo can be picked up. But can-not be sold, used or altered until FDA hold is lifted.
  2. Once cargo is in your possession, you must email FDA officer and us a full address of location, contact person, phone# and email.
  3. Your will given FDA contact: ( ___ - ___ - ___ ) email ( _______ ) officer name: ( _____ )
  4. FDA will contact you/importer directly, whether you could use or sell or destroyed / detention (confiscate/seize) by FDA or request more information or detain for investigation or shipment must be return to your vendor and etc.
  5. Some case you may need to pay for lab test + processing of IT / TE / IE / 7512 / 3499 = $195
  6. Normally it could take up-to 7 weeks for FDA to contact you.

If you think, it's not cost-effective to pay all the fees (duty/tax, forwarder, trucker, warehouse, ISF filing, customs entry filing, exam and etc. ) you could abandon your shipment. There are three choices, shipment that was refused by U.S. Customs/agencies. Sample of abandon letter (click here)

  1. Re-exporting back to vendor / exporting to other-country:
  1. To export, your must contact your freight forwarder, company that has done your transportation to us port. .
  2. Your current freight forwarder will be helping you with 7512 (ie / immediate exportation) form.
  3. Local U.S. Customs officer must sign and if any, agencies officer must sign a 7512 (ie / immediate exportation) form.
  4. Local = city, county, state that you are in.
  5. Who is liable: case file: federal court U.S. Attorney's (click here), importer is responsible for all laws/liable/fees/retroactive.
  1. Abandon your shipment. Please notify your supplier/us forwarder/carrier and warehouse and us by email only.
  1. For abandoning, you may be penalize / fines / demurrage / per-diem / destroy / trash / add-dpl and etc.
  2. Examples of other shipment that was abandon, refused by U.S. Customs/agencies and was not cost-effective.
  3. Who is liable: case file: federal court U.S. Attorney's (click here), importer is responsible for all laws/liable/fees/retroactive. For more: (here) (here) (here) (here)
  1. Destroy / trash email customs officer, warehouse and us by email only.
  1. If shipment is import with-out permit / permission hazard, patent, trademark and etc.
  2. You may be penalize / fines / demurrage / per-diem / destroy / trash / add-dpl and etc.
  3. Who is liable: case file: federal court U.S. Attorney's, importer is responsible for all laws/liable/fees/retroactive.

Note: Final ruling by U.S. customs/agencies for ISF filing (part 1-2) is 6 years and for customs entry filing (part 2-2) is 5 years.

  1. Customs broker = broker between U.S. Customs and importer only: to transmits importer info/documents, way it was received from you and your-vendors, to U.S. Customs
  2. Customs broker = is not a broker between you and your-vendors (factory / supplier / forwarder / warehouse / shipping-company / CET-exam site, us agencies and etc. )
  3. Please pay all your-vendors directly ( ASAP ), to avoid our $50. If amending/up-dating your entry filing. If entry must be refile (click here $)
  4. Importer is responsible for all fees/us laws/liability/exam/permit(s)retroactive(backdate) document (BL, arrival notice and etc. ) case file: federal court U.S. attorney's.
  5. Your responsibility = your shipment / money / profit / sells / documents / permit, your-vendors (factory/supplier/forwarder and etc. ), your arrangement/negotiation and etc.
  6. Exam notice by freight forwarder: LCL arrival notice, full container arrival notice. AD/CVD , fumigation, emergency action notifications can be $1,000's.
  7. Fumigating your shipment can be $7,205, vacuum cleaning can be $1,900 and A-TCET exam / intensive exam/stop sign / CET exam can be $1,843. 60 / $2,059. 90.
  8. If exam ( VACIS , NII, x-ray (reefer), IBET, MET, CET and etc,), your freight forwarder will be notifying with arrival notice and Invoice (pay your freight forwarder) (99% time).
  9. If exam ( CET exam , A-TCET exam, intensive exam/stop sign, IPR, tailgate, emergency action notifications and etc.), importer must pay directly to exam site. (100%)
  10. If importer / ID=( SSN number or tax-ID/EIN/IRS Number or CAN Number) or any info is off-by-one-digit/letter, U.S. Customs will confiscate/seize your shipment and penalize/fines you.
  11. And U.S. Customs/agencies can release with detention(hold)/hold/confiscate/penalize/fines/recall/examine/ ISF penalty/Re-ISF filing/issue destroy/re-export and etc.
  12. Bill of lading / BL (aka: Bill of Sale ) / original / OBL= arrival notice / manufacturers contract agreement / shipping terms = (title to shipment, provisions and etc.)
  13. You /importer/ consignee is fully responsible for all actions of payment (be aware of scam hijack emails and other scams).
  14. Before paying us, consignee must verify payment method and amount of payment, and such as our bank account number, western-union account number, check payable to and etc.
  15. Only valid communication is, if you/importer/consignee/your-vendors is communicating by phone number and email lists from our uscustomsclearing.com/contact-us

FDA Hold | Destroy Notice

Page 1: Diode Pump Solar Cell Laser Scribing Machine, Solar Cell Laser Cutter : HDMUQSWB5387372 / IB09022014

Page 2: Destroy Notice or Export back to supplier: HDMUQSWB5387372 / IB09022014
Sep 19 2014. Customs Release documents (Form 7501, 3641 & DO) & picked-up your shipment.

Page 3: Destroy Notice or Export back to supplier : HDMUQSWB5387372 / IB09022014
and US Customs / FDA issued can NOT NOT be use or sell & FDA officer contact was given to importer

Page 4: Destroy Notice or Export back to supplier : HDMUQSWB5387372 / IB09022014
Sep 22 2014. FDA office told importer to fill-out Form 2877 (www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm080778.pdf)

Page 5: Destroy Notice or Export back to supplier: HDMUQSWB5387372 / IB09022014
Sep 23 2014. Importer submitted Form 2877

Page 6: Destroy Notice or Export back to supplier : HDMUQSWB5387372 / IB09022014
Oct. 7 2014. FDA Reject: According to CDRH the Accession# provided is for the laser component itself.
Accession number is NOT for the finished laser unit (model GSC-50S)

Page 7 Destroy Notice or Export back to supplier : HDMUQSWB5387372 / IB09022014
Oct. 16 2014. Officer issued, will consider " Form 766 (reconditioning form) " (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM072766.pdf)

Page 8: Oct. 17 2014. Importer submitted " Form 766 (reconditioning form) "

Page 9: Destroy Notice or Export back to supplier (9-9 ): HDMUQSWB5387372 / IB09022014
Nov 19 2014. MUST "Destroy or Export" with 90 days.
FDA CDRH has communication with the foreign manufacturer to implemented " safety interlocks, user manual & etc.

Page 10: Destroy Notice or Export back to supplier ( 9-9 ): HDMUQSWB5387372 / IB09022014
9. Nov 19 2014. MUST "Destroy or Export" with 90 days.
FDA CDRH has communication with the foreign manufacturer to implemented " safety interlocks, user manual & etc.

Page 11. Destroy Notice or Export back to supplier: (Case# CHIWPIUA00R00) / EPA-3520-1
Entry has been denied on the vehicle because of the Replacement engine / 1983 Land Rover engine was replace (was 2.25L, replace with 2.5L)