i know the last thing this forum needs is another FDA thread, but check this out
OASIS REFUSALS INDUSTRY 80
so i was just flicking through the FDA customs, where it shows a list of the last 56 shipments that are held in customs. i looked at it yesterday and the day before and the whole page was filled with electronic cigarettes,. from looking at it right now, out of the 56 shipments siezed only ONE is for electric cigarettes/ and the rest are for random things like thermometors and first aid kits etc etc
ps technically there are 3 shipments being seized for electronic cigarettes, but they are all owned by "Hongkong Brother Union Inds.Co.Ltd" so i classed it as one.
the reason they are being seized is because:
Reason: NO 510(K)
Section: 801(a)(3); 502(o) Misbranding
Charge: It appears that a notice or other information
respecting the device was not provided to FDA, as required
by Section 510(k) and the device was not found to be
substantially equivalent to a predicate device.
so basically they might have branded it to be misleading (e.g. healthy product)
anyways long story short, i am not saying this proves anything,
but certainly a huge contrast compared to the last 7 days where the whole page
was just filled with shipments being siezed for electronic cigarettes.
so my next question is, are you suppliers and retailers who
ordered in bulk recieving your shipments that were held?
or are they shipped back to china?
OASIS REFUSALS INDUSTRY 80
so i was just flicking through the FDA customs, where it shows a list of the last 56 shipments that are held in customs. i looked at it yesterday and the day before and the whole page was filled with electronic cigarettes,. from looking at it right now, out of the 56 shipments siezed only ONE is for electric cigarettes/ and the rest are for random things like thermometors and first aid kits etc etc
ps technically there are 3 shipments being seized for electronic cigarettes, but they are all owned by "Hongkong Brother Union Inds.Co.Ltd" so i classed it as one.
the reason they are being seized is because:
Reason: NO 510(K)
Section: 801(a)(3); 502(o) Misbranding
Charge: It appears that a notice or other information
respecting the device was not provided to FDA, as required
by Section 510(k) and the device was not found to be
substantially equivalent to a predicate device.
so basically they might have branded it to be misleading (e.g. healthy product)
anyways long story short, i am not saying this proves anything,
but certainly a huge contrast compared to the last 7 days where the whole page
was just filled with shipments being siezed for electronic cigarettes.
so my next question is, are you suppliers and retailers who
ordered in bulk recieving your shipments that were held?
or are they shipped back to china?
