FDA rejecting my laser!! Anyone own a Sinjoe??
I recently purchased a Sinjoe CO2 laser and hired a broker to manage the shipping. Turns out there is something called an Accession number that neither I nor the broker, nor, apparently, the manufacturer, knew about. Now the FDA is saying that without it the machine will either be destroyed or shipped back to China. There is no alternative process the FDA has in place to make this work and they said its not uncommon (which I think is kind of crazy). Does anyone in the USA own a Sinjoe machine and how did you navigate this??
Re: FDA rejecting my laser!! Anyone own a Sinjoe??
Re: FDA rejecting my laser!! Anyone own a Sinjoe??
Wow, I'm really sorry to hear it. Unfortunately I can't help, but I am interested in what port the machine came through? It could help others in the future avoid this overzealous customs location. My own machine came via DHL with no issues but I have heard that this situation can happen.
Could you negotiate to have them remove the laser tube and ship the machine?
Re: FDA rejecting my laser!! Anyone own a Sinjoe??
Yeah, you need the FDA approval before it ships (and you pay). You should be able to get the brand of the tube and get a certificate from them....what I would try anyways.
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Re: FDA rejecting my laser!! Anyone own a Sinjoe??
Well, I got lucky. I had to get creative, and I have to leave it at that (PM me if you want specifics). I was able to send the FDA an accession number and an explanation about it that they accepted. Had I not pushed the envelope here in the way I am not describing I was promised by the FDA that the machine would be destroyed with no recompense. I had hired a broker that I had used in the past successfully and she did not know about accession numbers. I hired her because I did not expect that I could know and manage all the details of importing myself (thought I was being responsible and thorough by hiring an expert to handle it). Of course I wish she had been more competent but she is my sense fundamentally responsible and reliable and after going through this it seems this part of the FDA's procedures is exceptionally challenging (understatement) for a small business person to negotiate and very easily missed by all but the most specialized/experienced brokers.
Some manufacturers have these numbers and some don't, the FDA does not share the ones who do and don't (which is unhelpful to say the least), the manufacturers who don't have this number may or may not know they need it and there is no barrier to them making the mistake of sending a machine without it. What's more, that there is no other process in place by the FDA but to destroy machines that don't have the number is bleak.
The accession number is assigned by the FDA to Chinese companies after they fill out a form stating that their machine is radiation safe. The FDA may or may not inspect that company later and validate the claim. So, the accession number is often a "safety guarantee" by the FDA that was policed, essentially, by the Chinese manufacturer whose primary interest is selling machines and not safety of international users.
That the FDA doesn't offer to make one pay for an individual inspection or even a fine of some sort while giving one the chance to prove the product's viability is really minimalist and does not address the complexity and vulnerability that already makes up the import process.
I say this all so that, should someone else be looking for advice or feedback, they will hopefully find this and be better prepared to avoid this potential cliff themselves. I feel extremely fortunate to have gotten out without loss but if you heard my story you might be surprised that I did. I may be missing something here, in fact I am sure I am, and I am happy to hear any feedback. Obviously I am biased after going through this and would probably not even have looked at a thread like this had it not been my problem (so, thanks so much to those of you who offered time to help out.)
Re: FDA rejecting my laser!! Anyone own a Sinjoe??
Quote:
Originally Posted by
danielcoyle
Well, I got lucky. I had to get creative, and I have to leave it at that (PM me if you want specifics). I was able to send the FDA an accession number and an explanation about it that they accepted. Had I not pushed the envelope here in the way I am not describing I was promised by the FDA that the machine would be destroyed with no recompense. I had hired a broker that I had used in the past successfully and she did not know about accession numbers. I hired her because I did not expect that I could know and manage all the details of importing myself (thought I was being responsible and thorough by hiring an expert to handle it). Of course I wish she had been more competent but she is my sense fundamentally responsible and reliable and after going through this it seems this part of the FDA's procedures is exceptionally challenging (understatement) for a small business person to negotiate and very easily missed by all but the most specialized/experienced brokers.
Some manufacturers have these numbers and some don't, the FDA does not share the ones who do and don't (which is unhelpful to say the least), the manufacturers who don't have this number may or may not know they need it and there is no barrier to them making the mistake of sending a machine without it. What's more, that there is no other process in place by the FDA but to destroy machines that don't have the number is bleak.
The accession number is assigned by the FDA to Chinese companies after they fill out a form stating that their machine is radiation safe. The FDA may or may not inspect that company later and validate the claim. So, the accession number is often a "safety guarantee" by the FDA that was policed, essentially, by the Chinese manufacturer whose primary interest is selling machines and not safety of international users.
That the FDA doesn't offer to make one pay for an individual inspection or even a fine of some sort while giving one the chance to prove the product's viability is really minimalist and does not address the complexity and vulnerability that already makes up the import process.
I say this all so that, should someone else be looking for advice or feedback, they will hopefully find this and be better prepared to avoid this potential cliff themselves. I feel extremely fortunate to have gotten out without loss but if you heard my story you might be surprised that I did. I may be missing something here, in fact I am sure I am, and I am happy to hear any feedback. Obviously I am biased after going through this and would probably not even have looked at a thread like this had it not been my problem (so, thanks so much to those of you who offered time to help out.)
Hello danielcoyle, I am having the same problem with a laser from Jinan AOL CNC. My laser is being threatened to be destroyed pending review by FDA laser gods (FDA unknown). I also hired a broker and the Customs went through just fine and then the FDA put a hold intact order on it. I have jumped through their hoops and now waiting. The FDA did not ask for accession number, they said it is on the Red List. I am new to this forum and how lucky to find someone who has been there done that. I'm sorry but I don't know how to PM you. I am also new to the forum business. Do you have any suggestions that might help?
